Regulatory Compliance Specialist jobs at Johnson & Johnson

A leading blockchain solutions provider is seeking a US Counsel to manage its legal operations and ensure compliance with US regulations. This role involves working with teams on product development and regulatory requirements in a fast-paced environment. Candidates should have over 5 years of legal expertise, particularly in securities and digital assets, and must hold a JD with admission in at least one US jurisdiction. Join us in shaping the legal landscape of Web3. #J-18808-Ljbffr

SummaryThe Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory strategy and various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in the U.S. The Senior RA Specialist will also support related regulatory affairs activities, such as development, execution and management of procedures and systems to ensure that the product development process - including clinical studies and strategy - addresses all regulatory requirements and objectives of the business. The incumbent should have demonstrated leadership and success working in cross-functional teams and will perform essential duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Responsibilities: (Primary Duties, Roles, and/or Authorities) Understands and has expertise in US Pharmaceutical and OTC Monograph regulations and develops different regulatory pathways and communicates options to cross functional teams. Provides regulatory guidance for one or more program(s), including participation in external Food and Drug Administration (FDA) meetings, internal core team meetings and providing technical guidance on complex regulatory issues. Creates and manages programs with multiple workstreams and identifies key dependencies and critical path items. Develops and leverages working relationships with key personnel/representatives from FDA and oversees communications with regulators. Work with functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes. Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims. Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for changes to an approved (A) NDA Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses. Assess necessity for reporting changes to FDA for device modifications. Prepare robust justifications for changes that do not require notices. Address and resolve requests for additional information. Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives. Support OUS RA team members in order to maintain effective collaboration and to synchronize domestic and international submissions. Review and Approve Labeling and Advertising and Promotional materials for compliance to internal procedures. Manage and maintain the drug registrations and listings (CDER Direct/eDURLS) system and complete CARES Act reporting. Support the submission of SPL via ESG/CDER Direct for all drug labeling in the US. Evaluate and prepare procedures pertaining to corporate and departmental regulatory activities. Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents. Support the quality system and internal/external audits. Education and Experience: Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of five years of experience, with demonstrated support of regulatory submission development and approval from the FDA and other global regulatory agencies. Excellent organizational and communications skills. Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required. Experience navigating FDA databases required. Experience with EU MDR preferred. Experience with electronic submissions and ERP systems is preferred. Knowledge and Skills: Required Qualifications: Proficient in using Microsoft Word, Excel, PowerPoint, and OneNote. Strong communication (written, oral) and project management skills. Ability to plan and schedule multiple priorities in a concurrent fashion. Ability to review, collate and summarize scientific and technical data. Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. Excellent problem solving and analytical skills. Excellent written and oral communication skills with ability to effectively communicate at varying levels in the organization. Experience with authoring NDAs/ANDAs. (CTD Format) Experience authoring and managing regulatory submissions and/or registrations, with responsibility for communicating with regulatory authorities. Experience facilitating and designing communication strategies to FDA. Preferred Qualifications: Advanced degree Experience with regulatory tools and systems. (CDER Direct/eDURLS) Knowledge/Expertise of Quality Systems. Proven background managing complex and strategic regulatory projects from initiation to conclusion. Detail-oriented, methodical and able to handle regulatory information and submissions with a high degree of accuracy. Previous experience facilitating meetings with FDA, reviewing submissions, registrations and/or notifications from varying product lines or programs. Physical Demands: (if applicable) While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations. Work Environment: (if applicable) While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. This is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA RI - WarwickAdditional LocationsUSA IL - Vernon Hills, USA TX - El Paso - Northwestern Dr.Work Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $92,700.00 - $152,900.00 USD Annual

**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. **_Remote employees must reside in one of the following states: MD, VA, DC, PA, WV, CA, MI, IL, KS, FL, NC, or MN._** **Brief Job Overview** The Associate Hazard Communication Regulatory Compliance Specialist is an entry level position in USP's Hazard Communication Program (HCP), responsible for assisting in the preparation of Safety Data Sheets (SDS), hazard labels, and compliance with the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard. **How will YOU create impact here at USP?** As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The **Associate Hazard Communication Regulatory Compliance Specialist** has the following responsibilities: + [60 %] Under the supervision of senior staff, research toxicological, chemical, and physical properties of USP chemical products to determine acute and chronic human health hazards, physical hazards relating to fire and accidental release, and hazards to the environment and create safety data sheets and labels. + [40 %] Provide Handling Categories, potency evaluations, and any other requested safety information to USP staff and customers as required by law and as requested. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: + Bachelor's degree in chemistry or sciences-related discipline. + Excellent written and oral communication skills, especially the ability to communicate in a fast-paced, time-sensitive team environment. + Ability to research, think critically, analyze conflicting data, and evaluate information sources. + Highly organized with excellent attention to detail and able to work independently as well as an effective team member. + Proficiency in computer applications (MS Word, Excel) and database experience. **Additional Desired Preferences** + Knowledge of toxicology, industrial hygiene, hazard and risk communication, and chemical regulation. **Supervisory Responsibilities** None, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Hourly Range: USD $32.97 - $41.85 per hour. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Laboratory/Production **Job Type** Full-Time

Job Title: Manager, Regulatory & Trade Compliance Reports To: Director, Regulatory Compliance Work Type: Hybrid (3 days in office) FLSA Status: Exempt The Regulatory & Trade Compliance Manager will play a critical role in ensuring Antylia Scientific's sites operate in full compliance with global, federal, state, and local regulations. Supporting all Antylia divisions, this role will lead initiatives to strengthen both product compliance and operations compliance, ensuring that regulatory requirements are met while enabling business growth. Key Responsibilities: Directed global product compliance programs ensuring adherence to REACH, RoHS, PFAS, Prop 65, DOT dangerous goods, animal origin declarations, and other international product safety regulations. Led trade compliance activities, including HTS classification, ECCN determination, export license screening, and denied party / restricted party training to ensure compliance with U.S. and international export laws. Developed and delivered employee training programs on product safety, export controls, and regulatory requirements, improving awareness and reducing compliance risk across business units. Managed compliance documentation and certifications (COO, SDS, Prop 65 statements, REACH/ROHS declarations) to support sales, customer inquiries, and regulatory audits. Partnered with supply chain, quality, and operations teams to integrate compliance requirements into product lifecycle management, labeling, and shipping processes. Conducted internal audits and compliance risk assessments, implementing corrective actions to strengthen global compliance posture. Coordinate with R&D, Quality, and Supply Chain teams to evaluate the regulatory impact of product changes and development. Support global product compliance efforts including but not limited to label reviews, SDS generation, and product registration tracking. Maintain compliance documentation and product certifications to support customer and regulatory requests. Support site leaders in developing and executing site-specific compliance programs, audits, and corrective actions. Lead risk assessments and implement compliance frameworks to ensure adherence to US regulations (EPA, DOC, , etc.). Establish and track compliance KPIs across divisions, driving continuous improvement. Serve as a subject matter expert and compliance advisor to site leaders, business unit leaders, and functional teams. Conduct risk assessments and support the rollout of compliance frameworks under the guidance of the Director. Deliver compliance-related training and awareness initiatives to increase understanding of regulatory responsibilities. Support due diligence for mergers & acquisitions and integration of new businesses and products into Antylia's compliance framework. Act as the primary liaison with regulatory bodies, certification agencies, and third-party auditors for US operations. Performs other duties as assigned. Education: Bachelor's Degree in Regulatory Affairs, Life Sciences, or related field, or equivalent experience. Experience: Requires 5+ years of related experience Qualifications: Strong knowledge of US regulatory agencies (DOC, BIS, , EPA, , DOT) and global compliance requirements (REACH, RoHS, , GHS). Experience working in scientific, life sciences, or manufacturing industries preferred. Demonstrated ability to influence and collaborate with cross-functional teams in a matrixed, global organization. Excellent problem-solving, project management, and communication skills. Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other essential time constraints. Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization. Strong work ethic and an ability to excel within a rapidly changing and growing organization. Compensation & Benefits: Salary Range: $100,000-$115,000, depending on location, experience, and qualifications. Annual-Incentive Plan (AIP): 10% Benefits coverage begins day 1, including the following: Medical, Dental, Vision Insurance Disability Insurance Life Insurance 401(k) company match Paid Time Off (15 days annually) Paid Holiday time (10 company-designated days) Tuition Assistance Additional benefits available with company package This position has not been approved for Relocation Assistance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all the duties and responsibilities associated with it.

The Global Regulatory Specialist is responsible for the applied ingredients and regulatory compliance for consumer products with a focus on international documentation requirements. This role will assist with various projects, including formula and label reviews, product registration claims and support the work associated with obtaining government approval for product imports into international markets. Work Schedule: This position currently follows a hybrid work model. Employees are required to work from the office at least four days per week (Monday - Thursday), with Friday available for remote work, offering a blend of in-person collaboration and flexibility. Essential Duties & Responsibilities (Other duties may be assigned) Support internal areas by serving as a subject matter expert in assigned markets through interpretation of regulations and providing guidance in the development of products. Perform and ensure regulatory compliance of products, labels, advertising, and promotions as well as adherence to Isagenix policies and guidelines. Assist with identifying and maintaining procedures for the registration and exporting of ingredients and products into assigned markets. Review and ensure compliance and technical accuracy with formulation, label graphics, and ingredient claims. Interact with cross-functional staff across various business units, partners, contractors, lawyers, and government entities to support effective product registration and launch in assigned markets. Partner with R&D and other business teams to identify export processing and workflow opportunities. Stay abreast of international regulatory developments in multiple markets and identify opportunities and/or implications to the business. Maintain accurate and up-to-date regulatory records and databases. Assist with resolving regulatory issues pertaining to labeling and handle any complex issues or problems with minimal assistance. Possess comprehensive knowledge of subject matter. Minimum Qualifications (These are the requirements that all applicants MUST HAVE to be considered for this position) Bachelor's Degree from an accredited institution or equivalent experience. 1-3 years of experience in a consumer product regulatory affairs position. Preferred Qualifications Bachelor's Degree in food science, chemistry, biology, or related technical field. Bilingual Spanish and English Location : Company Overview Established in 2002, Isagenix International has created simple, proven products that optimize what your body is capable of-helping you protect your greatest asset, your health. For more than twenty years, Isagenix has made holistic science an art with transparency and integrity-creating products and systems that address nutrition, stress, fitness, energy, natural beauty, focus, and financial wellbeing. The global wellbeing company, based in Gilbert, Arizona, markets its products through a network of independent distributors in 22 key markets: the United States, Canada, Puerto Rico, Australia, New Zealand, Mexico, the United Kingdom, Ireland, the Netherlands, Belgium, Spain, Austria, Denmark, Finland, France, Germany, Italy, Norway, Poland, Portugal, Sweden, and Switzerland. For more information, visit Isagenix.com. Location : EEO Isagenix International, LLC is an equal opportunity employer and affords equal opportunity to all applicants for all positions without regard to race, color, religion, sex, national origin, age, disability, veteran status or any other status protected by law.

Works with International Product Managers to prioritize international product registrations and identify country specific regulatory requirements. Prepare and submit international regulatory submissions to support sales in key international markets. Interfacing with international country representatives, Notified Bodies and Representative for registrations and significant changes to products · Release regulatory ship holds once approvals are obtained. Work with International Customer Service to resolve routine order, ship holds for international shipments. Maintain databases to ensure international regulatory requirements for new registrations as well as design changes are current and up to date. Work with distributors and international partners to assess design, process, labeling changes to determine impact on existing registrations. Submit CFG applications to FDA; FSC applications to State of CA FDB and international agencies as applicable global labeling requirements in order to ensure compliant implementation post approval "}},{"field Label":"Skills","uitype":110,"value":"International regulatory requirements knowledge with a focus on China, Japan, Brazil, Mexico, Canada and MDD 93\/42\/EEC. Experience with Device registration on a global level Strong communication skills are a must"}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Apply Now","zsoid":"30142516","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"City","uitype":1,"value":"Carlsbad"},{"field Label":"State\/Province","uitype":1,"value":"CA"}],"header Name":"Regulatory Affairs Specialist","widget Id":"2**********0118069","is JobBoard":"false","user Id":"2**********0043003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"2**********1034076","FontSize":"12","location":"Carlsbad","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"fmv6cf7fa801b223c4cbf901e9c0ed9658cc2"}

SummaryWe are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is responsible for preparing and managing regulatory submissions to support the global commercialization of new or modified in vitro diagnostic (IVD) devices. The ideal candidate will have strong experience in international regulatory strategy, submission development, and cross-functional collaboration.Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Position Summary: We are seeking a Sr. International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is responsible for preparing and managing regulatory submissions to support the global commercialization of new or modified in vitro diagnostic (IVD) devices as well as research use only (RUO) products. The ideal candidate will have strong experience in international regulatory strategy, submission development, and cross-functional collaboration. This position requires identifying required documentation, management of submission to worldwide RA partners and working with cross functional teams to ensure that all data and information required for regulatory submissions and approvals are generated. Key Job responsibilities: Develop and execute international regulatory strategies for IVD device registrations outside the U.S. and EU. Gather information from international counterparts regarding submission pathways and impact of changes and support international counterparts in global regulatory submissions/approval. Prepare, coordinate, and manage regulatory submission documents for new products, renewals, and changes to existing products. Ensure compliance with global regulations and guidelines. Lead responses to regulatory agencies during submission and approval processes. Represent Regulatory Affairs in cross-functional product development teams. Evaluate design, manufacturing, and process changes for global regulatory impact. Review analytical and clinical protocols to ensure appropriate data collection for submissions. Review and approve product labels, labeling, and promotional materials for regulatory compliance. Provide regulatory support during internal and external audits. Conduct regulatory intelligence activities to monitor, analyze, and communicate evolving regulatory requirements in countries outside the U.S. and EU. Maintain awareness of international regulatory trends, guidance documents, and standards relevant to IVDs. Collaborate with regional RA teams and consultants to ensure timely updates and strategic alignment with local regulatory expectations. Required Skills/Experience: Bachelor's degree in science, math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience. 7+ years in the medical device, diagnostics, biologics, or pharmaceutical industry, with a focus on regulatory affairs. 3+ years of related regulatory submission experience from a medical device and/or IVD industry. Ability to work in a fast-paced environment and handle multiple projects simultaneously. Demonstrated ability to interpret and apply global IVD regulatory requirements. Experience with IVD and/or Medical device country registration/submission. Familiarity with ISO 13485/900, EU IVDR and US FDA 510 requirements. Experience with reviewing and approving product labeling, advertising and IFU's Excellent interpersonal skills with proven track record of building effective relationships internally and externally. Strong written and verbal communication skills across all organizational levels. Effective project management skills with the ability to prioritize and multitask. Strong analytical skills coupled with ability to think critically and solve problems independently. Detail-oriented with a proactive approach to problem-solving. Preferred Skills/Experience: Bachelor's degree in Science, Engineering, Pharmacy or equivalent field preferred but not essential provided candidate possesses sufficient relevant experience. Master's Degree (10+ years), Preferred RAC (Regulatory Affairs Certification) a plus. Medical Device Industry preferred - will consider other REGULATED Industry experience BILINGUAL Chinese/Mandarin would be beneficial but not essential. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Milpitas 135Additional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $92,700.00 - $152,900.00 USD Annual

About 3E:We are a mission-driven company with the purpose to enable a safer, more sustainable world! 3E provides a comprehensive suite of data, analytics, and software solutions for enabling and improving workplace & chemical safety, product stewardship, supply chain management and sustainability. With over 35 years of experience, and 15 locations across North America, Europe, and Asia, 3E helps more than 5,000 customers in various sectors to achieve safety, sustainability, and speed to market. Are you ready to shape the future? Come join us! About the Role:At 3E, we empower global companies to make confident, informed decisions in an increasingly complex regulatory landscape. As a North America Regulatory Specialist, you won't just be monitoring legislation-you'll be helping shape how compliance is understood, communicated, and acted upon across industries. This role is critical to our upstream insights function, where regulatory expertise meets AI innovation. You'll track high-impact chemical safety and environmental regulations across the U.S. and Canada, assess their implications, and help translate them into structured content and strategic guidance. Your insights will power 3E's products and services, inform customer decisions, and help shape the future of compliance intelligence. Success in this role means becoming the internal go-to for U.S. and Canadian regulatory developments. You'll deliver timely, actionable content to downstream teams, support AI agent training and validation, and play a visible role in how we present regulatory changes to the market-through expert's analysis article publications, client briefings, webinars, or industry panels. Whether you're looking to deepen your subject matter expertise, expand your exposure to AI-powered regulatory systems, or grow into a more client-facing, thought leadership-driven role, this is your opportunity to make a tangible impact-right where compliance meets innovation. This role is hybrid, with a strong preference for candidates located near our Bethesda, MD office. What You'll Do Monitor and analyze regulatory updates across federal and state/provincial agencies, including legislation, policies, and technical publications. Interpret regulations such as TSCA, OSHA, EPR, PFAS, GHS, and more to assess compliance impact. Draft clear, actionable regulatory summaries and support internal alerts and content systems. Collaborate with product teams, regulatory SMEs, and engineering to enhance 3E's compliance solutions. Help train and validate AI agents for source mapping, regulatory scanning, and logic modeling. Support the structuring of regulatory logic used in SDS authoring and hazard communication tools. Engage in internal knowledge sharing and cross-functional content validation. Participate in client briefings, webinars, workshops, or conference events as a regulatory expert. What Makes You a Great Fit Bachelor's degree in Chemistry, Environmental Science & Policy, Toxicology, Environmental Law, or a related field. 1-5 years of experience in chemical compliance, regulatory analysis, or EHS content development. Foundational knowledge of North American regulatory frameworks (TSCA, OSHA, GHS, etc.). Strong analytical and writing skills with the ability to translate legal language into practical insights. Comfort working with Excel, structured data systems, and digital/AI-based tools. Detail-oriented and highly organized, with strong documentation habits. Collaborative and proactive in cross-functional environments. Ability to manage multiple priorities and meet deadlines in a dynamic, fast-paced environment Pay Transparency: The anticipated salary range for this position is $75,000 - $80,000 per year. The final offer will depend on several factors, including the successful candidate's skills, depth of work experience, location, and relevant licenses/ qualifications. Each offer is determined based on individual strengths and relevant business considerations. In addition to the base salary, certain roles may qualify for a performance-based incentive and/or equity, with eligibility depending on the position. These rewards are based on a combination of company performance and individual achievements. Our US Benefits Include:Health, dental, and vision insurance Life insurance and disability coverage Generous PTO accrual and paid parental leave 401(k) plan with company matching Employee assistance program Voluntary supplemental benefits (Accident, Hospital Indemnity, Critical Illness) Disclosures:3E is committed to a diverse and inclusive work environment. 3E is an equal opportunity employer and does not discriminate based on race, nationality, gender, gender identity, sexual orientation, protected veteran status, age, disability, or any other legally protected status. For applicants who would like to request accommodation please send an email to ********************** Visit us at ********************* Follow us at ************************************************ and Candidate Privacy Notice Agencies: 3E is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at 3E via email, the Internet, or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of 3E. No fee will be paid in the event the candidate is hired by 3E because of the referral or through other means. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionDescription(Greenbelt, MD or Austin, TX) In this role, you will join the Regulatory Affairs Department, which provides regulatory, legislative, policy, and compliance counsel to JSI departments and JSI clients. Our department has nearly doubled this past year, adding more diverse expertise in federal and state communications policy and compliance - as our clients deploy more next-generation networks and connect more customers. We are looking for leaders to drive us into the future and individuals who are prepared to do whatever it takes to create a truly exceptional client experience every day. Key ResponsibilitiesThis role supports several different functions: Regulatory Reporting Perform daily management of JSI's web-based regulatory tracking tool to help clients mitigate risk and stay on top of their regulatory compliance requirements. This includes managing the internal tracking team and training new team members, interfacing with any third-party vendors, and ensuring client satisfaction. Ensure all projects are delivered on time within the stipulated scope and budget. Ensure resource availability and allocation. Coordinate and manage relationships with internal staff and clients. Perform product demos to potential clients and train staff on providing demos. Send proposals to potential clients and onboard new clients. Measure project performance using appropriate project management tools. Perform risk management analysis to reduce project risks. Report and escalate to upper management as appropriate. Create and maintain comprehensive project documentation. Perform policy and compliance research using internal tools and publicly available data, especially on state telecommunications regulatory matters. Other duties as assigned. Client and Business Development / Operational Excellence Prepare client communications, interest forms, templates, and tracking sheets. Manage proposal tracking system. Proofread and format documents and presentations for quality control. Monitor the Regulatory Support email account. Develop and maintain visual dashboards, Regulatory trackers, templates, and client pipelines. Update SharePoint Regulatory site Partner with the Vice President, Strategy & Operations Lead, Product Manager, and other leadership to drive operational excellence for the department and the company. Qualifications A bachelor's degree in communications or a related field. Any relevant project management-related experience Self-starter with a great attitude. Strong attention to detail and analytical skills Enjoys interacting with internal and external clients. Proficiency in software programs such as Microsoft Office (Outlook, Teams, Excel, Word, and PowerPoint), SmartSheets, and Adobe Acrobat Strong research skills Excellent organizational skills and the ability to manage and prioritize assignments in a fast-paced environment. Excellent written and oral communications skills. Ability to work well with individuals across diverse teams and cultures. BenefitsAt JSI, you will have a career that is rewarding and challenging on every level of the organization. JSI is committed to providing our employees with: Professional growth and development opportunities A diverse, dynamic, and stimulating work environment Educational opportunities A competitive salary and benefits package

SummaryThe Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. The RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Essential / Key Job Responsibilities (including supervisory and/or fiscal): Understands fundamental global regulatory requirements and different regulatory pathways. Understands scientific and health principles related to healthcare product development and regulations. Participates in core teams as regulatory lead, and provides guidance on regulatory requirements to product development teams, with some support from management. Organizes materials from preclinical and clinical studies for review and assists in the review process. Assists and/or has ownership in preparation of dossiers and submission packages for regulatory agencies. Supports development of regulatory strategies for marketing authorization for domestic and/or global markets. Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communicates changes to global regions and supports preparation of global notifications as needed. Assists in the preparation and sending of post-market reports and submissions. Participates in training of colleagues, as needed, for areas of expertise. Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends. Independently reviews advertising and promotional material for respective product line(s) and/or region(s) as needed. Maintains regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s). Assists in the preparation and sending of system effectiveness reports and summaries related to regulatory systems and tools, as applicable. May participate in regulatory body audits, as related to respective product line(s) and/or region(s). Required Qualifications: Bachelor's degree or Advanced degree in technical area such as biology, chemistry, engineering or medical-related field AND a minimum of one year of experience in a Regulatory role within the Medical Device industry Required. Will consider 5-7 years explicit Regulatory experience within the Medical Device industry in Lieu of education. Ability to plan and schedule multiple priorities in a concurrent fashion. Ability to review, collate, and summarize scientific and technical data. Ability to learn new technical concepts and skills. Good problem solving and analytical skills. Good written and oral communication skills. Preferred Qualifications: Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy. Ability to complete work with minimal supervision and ability to work independently. Previous experience in regulatory body audit support. Experience with regulatory tools and systems. Excellent writing and strong organizational skills. Performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations. Work Environment: While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. This is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork Shift

Our Regulatory & Clinical Affairs Specialist plays a vital role within our organization. Once you complete our training, your responsibilities will include the creation of and updates to Quva labels, Quva Bill of Materials (BOMs) at a corporate level (for all sites), maintenance of records with respect to product formulation and label information, and third-party submissions to external databases. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the Regulatory & Clinical Affairs Specialist Does Each Day: Organize, create, and update labels including finished goods and intermediate bulks Organize, create, and update product formulations and Bill of Materials Complete product formulations and labels in Master Control and Infor Update the LPL-picklist Prepare data and maintain records to ensure alignment with related systems and information Routinely evaluate FDA NDCs listing from Orange Book against approved products Prepare FDA Risk Evaluation and Mitigation Strategies Monitor for updates to FDA labeling requirements, 503B labeling standards and other relevant organization updates, such as ISMP, USP 7 and ASTM Manage submissions to 3rd party databases (First Data Bank, Cerner, Medi-Span, Merative) Support investigations for Pharmacy Services-related deviations and CAPAs, and initiate Pharmacy Services labels and formulations-related Change Requests Screen 503B facilities for FDA 483s on labeling issues Resolve discrepancies related to labels and or other tasks assigned. Delegate risk management issues with team Provide backup for the Pharmacy Services Labels and Formulations team for planned and unplanned tasks as needed Our Most Successful Regulatory & Clinical Affairs Specialist: Has a sense of urgency, accountability and resourcefulness (e.g., work in changing environment) Is a self-starter and independent learner Promotes active listening with team members; Contributes appropriately to conversations; Has strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform Minimum Requirements for this Role: Bachelor's degree in science 2+ years in an FDA cGMP environment Desire Quality or Pharmacy experience Efficiency with MS Office suite, Excel, PowerPoint 18+ years of age Able to successfully complete a drug and background check Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas Any of the Following Will Give You an Edge: College Major in Pharmacy or Chemistry Pharmacy certification/license Benefits of Working at Quva: Set, full-time, consistent work schedule Comprehensive health and wellness benefits including medical, dental and vision 401k retirement program with company match 17 paid days off plus 8 paid holidays per year National, industry-leading high growth company with future career advancement opportunities About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”

Our Regulatory & Clinical Affairs Specialist plays a vital role within our organization. Once you complete our training, your responsibilities will include the creation of and updates to Quva labels, Quva Bill of Materials (BOMs) at a corporate level (for all sites), maintenance of records with respect to product formulation and label information, and third-party submissions to external databases. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the Regulatory & Clinical Affairs Specialist Does Each Day: * Organize, create, and update labels including finished goods and intermediate bulks * Organize, create, and update product formulations and Bill of Materials * Complete product formulations and labels in Master Control and Infor * Update the LPL-picklist * Prepare data and maintain records to ensure alignment with related systems and information * Routinely evaluate FDA NDCs listing from Orange Book against approved products * Prepare FDA Risk Evaluation and Mitigation Strategies * Monitor for updates to FDA labeling requirements, 503B labeling standards and other relevant organization updates, such as ISMP, USP 7 and ASTM * Manage submissions to 3rd party databases (First Data Bank, Cerner, Medi-Span, Merative) * Support investigations for Pharmacy Services-related deviations and CAPAs, and initiate Pharmacy Services labels and formulations-related Change Requests * Screen 503B facilities for FDA 483s on labeling issues * Resolve discrepancies related to labels and or other tasks assigned. Delegate risk management issues with team * Provide backup for the Pharmacy Services Labels and Formulations team for planned and unplanned tasks as needed Our Most Successful Regulatory & Clinical Affairs Specialist: * Has a sense of urgency, accountability and resourcefulness (e.g., work in changing environment) * Is a self-starter and independent learner * Promotes active listening with team members; Contributes appropriately to conversations; Has strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization * Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform Minimum Requirements for this Role: * Bachelor's degree in science * 2+ years in an FDA cGMP environment * Desire Quality or Pharmacy experience * Efficiency with MS Office suite, Excel, PowerPoint * 18+ years of age * Able to successfully complete a drug and background check * Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas Any of the Following Will Give You an Edge: * College Major in Pharmacy or Chemistry * Pharmacy certification/license Benefits of Working at Quva: * Set, full-time, consistent work schedule * Comprehensive health and wellness benefits including medical, dental and vision * 401k retirement program with company match * 17 paid days off plus 8 paid holidays per year * National, industry-leading high growth company with future career advancement opportunities About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will."

Job DescriptionDescription(Greenbelt, MD or Austin, TX) In this role, you will join the Regulatory Affairs Department, which provides regulatory, legislative, policy, and compliance counsel to JSI departments and JSI clients. Our department has nearly doubled this past year, adding more diverse expertise in federal and state communications policy and compliance - as our clients deploy more next-generation networks and connect more customers. We are looking for leaders to drive us into the future and individuals who are prepared to do whatever it takes to create a truly exceptional client experience every day. Key ResponsibilitiesThis role supports several different functions: Regulatory Reporting Perform daily management of JSI's web-based regulatory tracking tool to help clients mitigate risk and stay on top of their regulatory compliance requirements. This includes managing the internal tracking team and training new team members, interfacing with any third-party vendors, and ensuring client satisfaction. Ensure all projects are delivered on time within the stipulated scope and budget. Ensure resource availability and allocation. Coordinate and manage relationships with internal staff and clients. Perform product demos to potential clients and train staff on providing demos. Send proposals to potential clients and onboard new clients. Measure project performance using appropriate project management tools. Perform risk management analysis to reduce project risks. Report and escalate to upper management as appropriate. Create and maintain comprehensive project documentation. Perform policy and compliance research using internal tools and publicly available data, especially on state telecommunications regulatory matters. Other duties as assigned. Client and Business Development / Operational Excellence Prepare client communications, interest forms, templates, and tracking sheets. Manage proposal tracking system. Proofread and format documents and presentations for quality control. Monitor the Regulatory Support email account. Develop and maintain visual dashboards, Regulatory trackers, templates, and client pipelines. Update SharePoint Regulatory site Partner with the Vice President, Strategy & Operations Lead, Product Manager, and other leadership to drive operational excellence for the department and the company. Qualifications A bachelor's degree in communications or a related field. Any relevant project management-related experience Self-starter with a great attitude. Strong attention to detail and analytical skills Enjoys interacting with internal and external clients. Proficiency in software programs such as Microsoft Office (Outlook, Teams, Excel, Word, and PowerPoint), SmartSheets, and Adobe Acrobat Strong research skills Excellent organizational skills and the ability to manage and prioritize assignments in a fast-paced environment. Excellent written and oral communications skills. Ability to work well with individuals across diverse teams and cultures. BenefitsAt JSI, you will have a career that is rewarding and challenging on every level of the organization. JSI is committed to providing our employees with: Professional growth and development opportunities A diverse, dynamic, and stimulating work environment Educational opportunities A competitive salary and benefits package

States considered: Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in Lincoln and we continue to grow. Benefits Include: $500 sign on bonus! Great Health Benefits from day 1! 4 weeks accrued paid vacation and 13 paid holidays 401(k) match with company profit sharing Tuition reimbursement Position Summary Manage US domestic and international regulatory compliance activities for Lincoln Operations with emphasis on USDA, DEA and FDA activities, registration change controls (including defending technical data to country authorities), serial variations, market actions/recalls, artwork review and approval and annual compliance reviews (Outlines of Production & Administrative Audit). This position serves as the principle back-up to the Primary Liaison for the USDA Center of Veterinary Biologics Inspection & Compliance. Position Responsibilities Manage the completion of the following responsibilities: Manage all site DEA registrations. Ensure all regulatory requirements are met. Serve as a key Zoetis Establishment 190 representative to USDA & international regulatory colleagues and agencies regarding compliance and registration support activities. Perform, review, and approve investigations into biological product complaints to ensure products released in the market are safe, pure, potent, and efficacious. Perform periodic trending of complaints and identify opportunities for product improvements to eliminate product defects. Ensure investigations meet the requirements and expectations of the relevant regulatory authority. Present periodic trends to LSQC. Manage pharmaceutical and biological registration change control, including the annual outline of production review, QQFs and RCR/SARs. Support/assist with miscellaneous regulatory support functions such as the annual administrative inspection review, market actions/recalls, periodic blueprint & legend updates and artwork review and approval. Assess and determine need for regulatory notifications. Defend registration process deviations (variations) to USDA and other appropriate regulatory agencies. Monitor regulatory communications and ensure that any commitments to the agencies are endorsed by leadership and communicated. Ensure commitments are met and/or communicate progress to the regulatory authority. Maintain a thorough knowledge of USDA, FDA and DEA regulatory requirements associated with the testing and manufacturing of veterinary products. Advise management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements. Participate in industry and trade association committees to align Zoetis Quality Standards, government regulations, and the quality needs of Animal Health customers. Organizational Relationships Interact with Manufacturing, QA, QC, VMRD, Pharmacovigilance and VMIPS. Interface and interact with other USDA Establishment License 190 Facilities. Education and Experience D.V.M. and/or Ph.D. with 5 years, M.S. with 7 years, B.S. with 10 years or equivalent in biological or pharmaceutical sciences, or related discipline. Technical Skills and Competencies Required Minimum Qualifications: In-depth knowledge of USDA, DEA, and FDA regulatory requirements for an international veterinary biological/pharmaceutical manufacturing site. Excellent written, oral, and interpersonal skills and ability to work in a team environment Demonstrated ability to perform and reach targeted conclusions. Ability to establish appropriate timelines to meet project milestones and timelines. Process and detail oriented with the ability to review and/or prepare detailed structured documents. Ability to develop solutions to routine and complex problems. Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work. Ability to communicate effectively with Team Members to facilitate completion of required investigation activities to meet all deadlines. Preferred Qualifications: Demonstrated experience in the ability to influence and negotiate with external regulators. Demonstrated experience performing and/or approving investigations into deviations and/or product complaints. Demonstrated knowledge of the deviation, change control, laboratory information management and manufacturing systems. Physical Position Requirements This position requires sitting, standing, and walking with occasional overtime/weekend work. Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Full-time Description Join Safeguard Medical - Where Purpose Meets Innovation At Safeguard Medical, we're not just shaping the future of emergency medicine-we're saving lives. We combine deep expertise with world-class equipment to empower first responders to act confidently and effectively when every second counts. Our mission is clear: To equip and enable responders at every skill level to preserve life in any environment. Our vision is bold: To simplify emergency medicine so that all responders have the confidence and tools to intervene when it matters most. Our purpose is powerful: To bring together life-saving products and the knowledge of emergency medical skills that preserve life. From category-leading medical devices to hyper-realistic SIMBODIES simulations, and a presence in key markets around the world, we're building a global movement-one that gives first responders the tools they need to make a difference in the toughest conditions. If you're driven by impact, inspired by innovation, and ready to grow in a company that's changing lives-this is your moment. About the Role We're on the lookout for a passionate Regulatory Specialist to join our team onsite full time in Huntersville, NC. This isn't just a job-it's a chance to be part of something bigger. At Safeguard Medical, every role plays a part in our mission to preserve life and deliver excellence across the globe. What You'll Be Doing in This Role As a Regulatory Specialist, you'll be right at the heart of our mission to preserve life. The Regulatory Affairs Specialist will be responsible for activities related to execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position is versatile and executes various activities with both RA compliance and RA submission responsibilities. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory compliance and submission processes. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide. Your key objectives: • Reviewing labeling, training, and promotional material • Supporting product and shipping release. • Maintaining FDA's GUDID database • Updating and reviewing technical file updates • Reviewing External Standards • Supporting business with government queries and registration documentation requirements. • Reviewing Change Orders and assessing regulatory impact of product changes on US and/or International regulatory strategy and submissions • Supporting post market regulatory compliance activities for US/International product approvals • Assisting with the development and maintenance of regulatory affairs department procedures • Complying with applicable FDA and international regulatory laws/standards • Ensuring relevant ISO and FDA Export requirements are met, as required • Performing coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. • Ensuring all materials comply to support submissions, license renewal and annual registrations. • Keeping abreast of regulatory procedures and changes. • Providing support to Customer Service Requirements You won't just be filling a role-you'll be making a difference. Every decision, every action, every idea you bring to the table helps responders around the world save lives when it matters most. Is This You? We're looking for someone who's ready to jump in and make a difference. Could that be you? You thrive in a team and bring a positive, can-do attitude to everything you do You're passionate about helping others and want to be part of something that truly matters in emergency medicine Ability to focus and achieve scheduled milestones, including contingency planning. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed. Exercise outstanding judgment in all areas of responsibility. Ability to travel up to 15% You possess the following: · Bachelor's Degree required · At least 2 years of Regulatory Affairs experience in Medical device · Working knowledge of relevant domestic and global regulations and guidance · History of successful interactions with global regulatory authorities · Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities. Technical competence includes the ability to learn new software and systems. · A combination of education and experience may be considered · Knowledge of FDA, MDD, EU MDR · Knowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility). · RAC certification is a plus If you're nodding along, we'd love to hear from you. Why Safeguard Medical? This is more than a career move-it's a chance to join a fast-paced, purpose-led company where your work truly matters. You'll be surrounded by passionate people, cutting-edge products, and endless opportunities to grow. Be part of a mission-driven organization with global impact Work with life-saving technologies and innovative solutions Join a collaborative, supportive, and inclusive team Build your career in a company that invests in people and progress Our Culture: Powered by Our DNA At Safeguard Medical, our culture is built on values that drive us every day: Ownership - We take charge, own our impact, and push for success. Initiative - We act boldly and do what's right, fast. Curiosity - We ask “why?”, explore better ways, and embrace diverse views. Candor - We speak openly and respectfully to align and move forward. Humility - We lead selflessly, knowing success is shared. We believe in learning from each other, valuing every voice, and creating a space where everyone belongs-regardless of background, identity, or ability. What You'll Get in Return We believe great people deserve great rewards. Here's what we offer to support your wellbeing, growth, and success Comprehensive insurance packages - peace of mind for you and your loved ones with medical, dental, vision and life insurance Competitive pay & performance bonus - because your impact deserves recognition Retirement support - employer contribution to help secure your future Generous time off allowance - time to recharge and enjoy life outside of work Employee Assistance Program (EAP) - confidential support when you need it most Tuition reimbursement &referral programs - invest in your growth and help us grow too Ready to Make a Difference? Ready to join our team? We'd love to hear from you. Click here Safeguard Medical - Job Opportunities to learn about future opportunities. Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. The above statements are not an exhaustive list of all required responsibilities, duties and skills for this job classification.

Job Details Scientific Protein Laboratories - Waunakee, WIDescription Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Regulatory Affairs Specialist. This position is responsible for supporting day to day Regulatory Affairs (RA) activities at SPL, Mobren as well as supporting external customer requests. Responsibilities include maintaining and responding to established timelines for reports such as Drug Master Files (DMF) and annual updates/amendments in compliance with ICH Q7, 21 CFR 314.420 and other regulations as applicable. Strong oral and listening communication skills are required to support external and internal customers as well as regulatory agencies. Exceptional writing skills supporting technical subjects and regulatory documents are essential. Attention to detail and working independently with minimal supervision is required. This position is 100% on-site. Responsibilities include: Prepares global regulatory documentation and registration in support of customers and SPL business objectives. Prepares and maintains Drug Master Files (DMF) for U.S. FDA. Keeps with current EC drug substance or Active Pharmaceutical Ingredient (API) regulatory requirements. Keeps current on U.S. FDA cGMP requirements. Keeps current with Code of Federal Regulations (CFR) requirements for applications to DMF, IND and NDA documents. Participates and supports customer and regulatory agency inspections. Responsible for reviewing Quality Systems documents such as Change Controls and assessing applicability to the RA department. Assists with reports and recommendations supporting updates and changes to evolving regulatory requirements. Independently organizes, manages and meets critical timelines for regulatory activities. Responsible for using electronic submissions formats such as Electronic Common Technical Document (ECTD). Possesses good computer skills and apply this knowledge to new applications as needed. Critical thinker with attention to details and the ability to articulate regulatory position or opinion to others in multi departmental meeting. Maintains knowledge about regulations and regulatory trends for the U.S.A, Canada and EC. Maintains knowledge about USDA importation and exportation requirements. As needed assists with Annual Product Reviews (APR) and ensures correct information is captured in the regulatory files. Performs other duties as assigned. Job Requirements and Qualifications: Education: Bachelor's degree in a scientific or preprofessional field required Experience: 2 plus years applicable GMP experience WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

Job DescriptionDescription: Join Safeguard Medical - Where Purpose Meets Innovation At Safeguard Medical, we're not just shaping the future of emergency medicine-we're saving lives. We combine deep expertise with world-class equipment to empower first responders to act confidently and effectively when every second counts. Our mission is clear: To equip and enable responders at every skill level to preserve life in any environment. Our vision is bold: To simplify emergency medicine so that all responders have the confidence and tools to intervene when it matters most. Our purpose is powerful: To bring together life-saving products and the knowledge of emergency medical skills that preserve life. From category-leading medical devices to hyper-realistic SIMBODIES simulations, and a presence in key markets around the world, we're building a global movement-one that gives first responders the tools they need to make a difference in the toughest conditions. If you're driven by impact, inspired by innovation, and ready to grow in a company that's changing lives-this is your moment. About the Role We're on the lookout for a passionate Regulatory Specialist to join our team onsite full time in Huntersville, NC. This isn't just a job-it's a chance to be part of something bigger. At Safeguard Medical, every role plays a part in our mission to preserve life and deliver excellence across the globe. What You'll Be Doing in This Role As a Regulatory Specialist, you'll be right at the heart of our mission to preserve life. The Regulatory Affairs Specialist will be responsible for activities related to execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position is versatile and executes various activities with both RA compliance and RA submission responsibilities. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory compliance and submission processes. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide. Your key objectives: • Reviewing labeling, training, and promotional material • Supporting product and shipping release. • Maintaining FDA's GUDID database • Updating and reviewing technical file updates • Reviewing External Standards • Supporting business with government queries and registration documentation requirements. • Reviewing Change Orders and assessing regulatory impact of product changes on US and/or International regulatory strategy and submissions • Supporting post market regulatory compliance activities for US/International product approvals • Assisting with the development and maintenance of regulatory affairs department procedures • Complying with applicable FDA and international regulatory laws/standards • Ensuring relevant ISO and FDA Export requirements are met, as required • Performing coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. • Ensuring all materials comply to support submissions, license renewal and annual registrations. • Keeping abreast of regulatory procedures and changes. • Providing support to Customer Service Requirements: You won't just be filling a role-you'll be making a difference. Every decision, every action, every idea you bring to the table helps responders around the world save lives when it matters most. Is This You? We're looking for someone who's ready to jump in and make a difference. Could that be you? You thrive in a team and bring a positive, can-do attitude to everything you do You're passionate about helping others and want to be part of something that truly matters in emergency medicine Ability to focus and achieve scheduled milestones, including contingency planning. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed. Exercise outstanding judgment in all areas of responsibility. Ability to travel up to 15% You possess the following: · Bachelor's Degree required · At least 2 years of Regulatory Affairs experience in Medical device · Working knowledge of relevant domestic and global regulations and guidance · History of successful interactions with global regulatory authorities · Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities. Technical competence includes the ability to learn new software and systems. · A combination of education and experience may be considered · Knowledge of FDA, MDD, EU MDR · Knowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility). · RAC certification is a plus If you're nodding along, we'd love to hear from you. Why Safeguard Medical? This is more than a career move-it's a chance to join a fast-paced, purpose-led company where your work truly matters. You'll be surrounded by passionate people, cutting-edge products, and endless opportunities to grow. Be part of a mission-driven organization with global impact Work with life-saving technologies and innovative solutions Join a collaborative, supportive, and inclusive team Build your career in a company that invests in people and progress Our Culture: Powered by Our DNA At Safeguard Medical, our culture is built on values that drive us every day: Ownership - We take charge, own our impact, and push for success. Initiative - We act boldly and do what's right, fast. Curiosity - We ask “why?”, explore better ways, and embrace diverse views. Candor - We speak openly and respectfully to align and move forward. Humility - We lead selflessly, knowing success is shared. We believe in learning from each other, valuing every voice, and creating a space where everyone belongs-regardless of background, identity, or ability. What You'll Get in Return We believe great people deserve great rewards. Here's what we offer to support your wellbeing, growth, and success Comprehensive insurance packages - peace of mind for you and your loved ones with medical, dental, vision and life insurance Competitive pay & performance bonus - because your impact deserves recognition Retirement support - employer contribution to help secure your future Generous time off allowance - time to recharge and enjoy life outside of work Employee Assistance Program (EAP) - confidential support when you need it most Tuition reimbursement &referral programs - invest in your growth and help us grow too Ready to Make a Difference? Ready to join our team? We'd love to hear from you. Click here Safeguard Medical - Job Opportunities to learn about future opportunities. Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. The above statements are not an exhaustive list of all required responsibilities, duties and skills for this job classification.

Requirements Qualifications • Dependability and willingness to accommodate work schedule. • Ability to fulfill internal customers' needs while following company policies and procedures. • Strong verbal and written communication skills; ability to speak clearly and effectively convey complex or technical information at the executive level. • Demonstrate a self-confident approach to complete work assignment or defend a position or idea. • Ability to use appropriate interpersonal styles and communication methods to gain acceptance of a product, service, or idea. • Portray flexible and multi-tasking abilities. • Strong time management, organizational, and prioritization skills. • Clarity of communication is needed to determine the effectiveness of the performance in the entire sales operation department. • Actively listen, attend to, convey, and understand the comments and questions of others. • Accept responsibility and account for his/her actions. • Ability to resolve antagonistic conflicts with others in a professional manner. • Goal oriented with the desire to perform to the best of his/her ability. • Adept problem solver and show the ability to think quickly. Skills and Abilities Education: Bachelor's degree (four-year college or technical school) in business, healthcare administration, criminal justice, or a related field a plus; or work equivalent. Experience: 2-4 years of experience in compliance, regulatory affairs, auditing, or pharmaceutical distribution preferred. Computer Skills: Must be proficient in Microsoft suite of products including Word and Outlook. Proven proficiency in Microsoft Excel, including pivot tables, formulas, data analysis, and report/dashboard creation. Other Skills • Strong knowledge of state and federal regulations impacting pharmaceutical distribution; familiarity with Suspicious Order Monitoring Systems (SOMs) a plus. • Experience reviewing new accounts and conducting customer licensing due diligence required. • Excellent analytical and investigation skills with a high attentional to detail. • Strong verbal and written communication, including the ability to document findings and prepare clear reports. • Ability to manage multiple priorities and meet deadlines in a fast-paced regulatory environment. • Strong customer service skills Salary Description $24.50/hour

The compliance specialist is responsible for monitoring and ensuring adherence to federal, state, and industry regulations in pharmaceutical distribution. This role involves reviewing new account applications, conducting licensing due diligence, monitoring orders for unusual activity, and reviewing data to detect compliance risks. In addition, will collaborate with internal team to promote a culture of compliance and operational integrity. Essential Functions Review new customer account applications to ensure completeness, accuracy, and proper licensing. Perform due diligence on new accounts by verifying documentation, licensing status, and regulatory requirements. Review and monitor orders to identify, investigate, and document unusual or suspicious activity. Analyze customer purchasing patterns using excel functions (pivot tables, formulas, dashboards) to detect irregularities or potential diversion. Conduct periodic audits of customer accounts, licensing, and order histories to ensure ongoing compliance. Prepare compliance reports, dashboards, and summaries for management review. Monitor regulatory requirements (FDA, DEA, state boards of pharmacy) and ensure company practices remain compliant. Collaborate with sales, operations, and customer service teams to address compliance-related issues and ensure proper account on boarding. Assist in preparing responses to regulatory inquiries, inspections, and audits. Recommend process improvements to strengthen internal controls and reduce compliance risk. Perform other duties as assigned. Requirements Position Qualifications • Dependability and willingness to accommodate work schedule. • Ability to fulfill internal customers' needs while following company policies and procedures. • Strong verbal and written communication skills; ability to speak clearly and effectively convey complex or technical information at the executive level. • Demonstrate a self-confident approach to complete work assignment or defend a position or idea. • Ability to use appropriate interpersonal styles and communication methods to gain acceptance of a product, service, or idea. • Portray flexible and multi-tasking abilities. • Strong time management, organizational, and prioritization skills. • Clarity of communication is needed to determine the effectiveness of the performance in the entire sales operation department. • Actively listen, attend to, convey, and understand the comments and questions of others. • Accept responsibility and account for his/her actions. • Ability to resolve antagonistic conflicts with others in a professional manner. • Goal oriented with the desire to perform to the best of his/her ability. • Adept problem solver and show the ability to think quickly. Skills and Abilities Education: Bachelor's degree (four-year college or technical school) in business, healthcare administration, criminal justice, or a related field a plus; or work equivalent. Experience: 2-4 years of experience in compliance, regulatory affairs, auditing, or pharmaceutical distribution preferred. Computer Skills: Must be proficient in Microsoft suite of products including Word and Outlook. Proven proficiency in Microsoft Excel, including pivot tables, formulas, data analysis, and report/dashboard creation. Other Skills • Strong knowledge of state and federal regulations impacting pharmaceutical distribution; familiarity with Suspicious Order Monitoring Systems (SOMs) a plus. • Experience reviewing new accounts and conducting customer licensing due diligence required. • Excellent analytical and investigation skills with a high attentional to detail. • Strong verbal and written communication, including the ability to document findings and prepare clear reports. • Ability to manage multiple priorities and meet deadlines in a fast-paced regulatory environment. • Strong customer service skills Salary Description $24.50/hour