Regulatory specialist entry level jobs - 5 jobs

**About the Role:** At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). You will help prepare the required documentation to register products in global markets where the products are sold. You will establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope. You will work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable. You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work. **About the Business:** Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracle's technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracle's Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery. **What You'll Do:** + Work closely with Oracle's product engineering teams to assess product functionality and develop regulatory strategy. + Collaborate cross-functionally with other teams to create and manage pre-market submissions (including 510(k), CE Marking under EU MDR, Technical Files, applications to Health Canada, and other global submissions) across global market ensuring compliance with regulatory authorities. + Maintain documentation and post market surveillance report on an ongoing basis to maintain market authorization. + Support internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies. + Serve as a subject matter expert for internal clients with interpretation of applicable standards and regulations, and use of the quality management system. + Manage and compliance related projects for Health-related products. + Review and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures to maintain regulatory and quality compliance. + Maintain compliance with changing regulatory requirements across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. **Responsibilities** **Preferred Qualifications:** + BA/BS or advanced degree preferred. + Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU Tech Files, etc.) required. Experience with sustaining and new product development is ideal. + Experience interacting with notified bodies and/or regulators preferred. + Ability to perform in a fast-paced and continually evolving business environment. + RAC, CQE, CPPS, CQA desired. + Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations. + Understands continual improvement and risk management. Excellent written and verbal communication skills. + Ability to adjust and adapt to changing priorities in a dynamic environment. Disclaimer: Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates. Oracle uses Artificial Intelligence in our recruiting process. Read more about it in our Recruiting Privacy Policy (**************************************************************** . **Range and benefit information provided in this posting are specific to the stated locations only** CA: Hiring Range in CAD from: $78,500 to $128,500 per annum. US: Hiring Range in USD from: $87,000 to $178,100 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC4 Vacancy Type - New Position This role will be working on a regular basis with colleagues around the world. To support this collaboration, knowledge of English is required for this role. Proficiency in French is required for candidates residing in Quebec, otherwise it is considered an asset. **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

Responsible for tracking pharmacist licensure and technician certification (in applicable states) and required corrective action plans (CAP), and following up with divisions on outstanding CAPS. Keen attention to detail and communication skills are key elements in this position, as is the ability to manage a diverse workload in a timely manner. Provide outstanding customer service to the divisions and members of the Health & Wellness (H&W) compliance team. Provide general administrative and creative support to the H&W Compliance team. Demonstrate the company's core values of respect, honesty, integrity, diversity, inclusion and safety. Minimum Excellent planning, organizing and follow up skills with attention to detail The ability to be self-directed and work independently, as well as participate on group projects. Proficient Word, Excel, and Outlook Ability to organize and prioritize work based on changing and challenging deadlines Strong written and oral communication skills Desired Bachelor's degree Pharmacy technician experience Administrative experience Manage surety bond process Manage invoices for department Draft slides and minutes for the department's compliance committee meetings (i.e., Kroger Health, retail pharmacy and The Little Clinic) Track and monitor the resolution of audit deficiencies and corresponding corrective action plans Follow up with Division Health Leaders and Pharmacy Practice Coordinators on outstanding CAPs Maintain accreditation spreadsheet. Assist with special projects at the direction of the Kroger Health Compliance Officer Provide administrative support for department Ability to handle confidential/sensitive information and make sound decisions Ability to work cooperatively in high paced and sometimes stressful environment Ability to manage conflict in a reasonable, nonconfrontational and cooperative manner Ability to act with honesty and integrity regarding customer and business information Ability to follow directions and seek assistance when necessary to resolve customer and business issues Provide support and assistance through direct interaction with minors, individuals with special needs, and/or older adults Must be able to perform the essential functions of this position with or without reasonable accommodation

North American Properties and its portfolio companies believe that it all comes down to connections-people to each other; cities to their souls; partners to opportunities; and individuals to experiences that move them. We believe that by fulfilling people's desire for connectedness, we're creating happier places and experiences that in turn become more successful environments, more vibrant communities and ultimately, a better world. Since 1954, we've balanced a well-capitalized approach and a keen focus on successful execution with a willingness to question conventional wisdom, reimagining and expanding the possibilities for more than $7 billion of assets across the US. Whether developing multifamily, mixed-use, office, student housing, hotel or retail environments, we're driven to deliver more valuable, meaningful real estate and ventures that transform, inspire, delight and succeed by connecting us all with what matters most. ӗleeo brands is a household of thoughtful, high-quality, family-focused health & wellness brands that ensure a healthier, happier life is always within reach. We are seeking a Quality & Regulatory Affairs Manager for our Operations Team. Job Description The Manager of Regulatory Affairs & Quality will work directly with internal and external teams to ensure that all products meet quality and varying retail standards, are safe to use by consumers and that any human-related safety or regulatory-related copy claims and endorsements are allowable, tested and substantiated. This position is also responsible for assuring all products comply with any applicable US and Canadian regulations and requirements. These include but are not limited to listing and maintaining products with the FDA (Cosmetic, Drug and Food and Supplement), EPA, FIFRA, CPSC, INDA and ongoing state-specific regulations and registrations. This Manager is not expected to be expert in all regulatory and safety areas affecting the company, but can leverage outside consultants to inform the company's regulatory and product safety needs and facilitate execution against these needs. This individual is expected to be a team player and flex as needed based on broader team needs. Responsibilities will include: Proactively and positively work with and serve as a resource to the operations, quality, product development and marketing teams. Onboard new and existing suppliers with Supplier Standards, maintain a repository of documents provided and ask suppliers for updated documents as needed. Work with internal and external stakeholders to track and approve finished good quality documentation and investigate and resolve product quality issues if they arise. Collaborate with suppliers and formulators to identify acceptable raw material alternatives and replacements in order to react to supply chain disruptions and/or identify cost saving Manage and develop regulatory & quality documentation across all products and raw materials (SDS, Formula Cards, Certificates of Analysis, Spec Sheets, Naturally Derived Statements, etc; with consultative or 3rd party support if needed). Assist in new product development, reviewing all potential raw materials and formulas, and labels against key internal and external policies, standards and regulations. Inform and provide guidance on all labeling and marketing copy and manage internal processes for tracking and substantiation: claims, cautionary statements, use directions, drug facts, supplement facts, DOT regulations, Ensure all products fully comply with related Federal and State regulations (FDA Cosmetics, FDA Drugs, FDA Food, EPA and Cleaning Product Regulations). Ensure all products and business practices fully comply with varying retailer requirements and coordinate related testing if needed. Ensure all data, product certifications, SDSs, and other key information are loaded into and reflected correctly on our website(s) and other online portals like WERCS, SmarterX and Label Insights. Relay, manage and coordinate any required product testing: claims, endorsements (i.e. Clean Label Project, USDA Organic, Non-GMO), performance, safety/toxicity, micro, human testing, retail compliance, etc. Manage regulatory related licenses and registration (i.e. Oregon Board of Pharmacy) Manage product formulation, regulatory and safety inquiries that come from retailers, consumers, suppliers or other external parties. Proactively track (with the help of outside consultants and via participation in trade associations) the key regulatory trends that could impact the business and summarize potential implications and recommendations regarding these trends. Qualifications/Requirements: Regulatory experience required, Quality and/or Operations experience preferred Project Management experience is not required but advantageous Strong working knowledge of Microsoft Office & Google for Businesses Solid organizational skills and attention to detail Excellent written and verbal communication skills Lead and direct the work of others and manage up if needed Bachelor's Degree in appropriate field of study or equivalent work experience Preferred Skills: Knowledgeable in Organic Product Certification and Labelling Standards under USDA and NSF/ANSI 305. Familiar with Product Labelling/Claims Regulations in the Food, Cosmetics and Cleaning Products areas (FDA, MoCRA, CPSC, Prop 65, CA SB258 among others). Experience with similar International Regulations is a +. Previous knowledge of FDA online reporting portals (FEI, NDC, MoCRA, SPL, COSM, 510k Device) is a +. Interested candidates should forward their resume and references to *********************** Regulatory Affairs & Quality Manager in the subject line. About North American Properties NAP upholds a professional and deadline‐oriented working environment in an office setting. At NAP, we live our values of Relationships, Ownership, Agility, Strength, and Stability, Courage and Creativity, Empowerment, and Integrity. North American Properties does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. We look forward to hearing from you!

About Us Orveon is a new kind of beauty company launched in December 2021 when we acquired our three iconic brands - bare Minerals, BUXOM, and Laura Mercier. With more than 600 associates, operating in 40+ countries, we're truly a global business. Our headquarters are in New York, with additional locations in major cities worldwide. We love our brands and are embarking on a powerful shift: To change how the world thinks about beauty. We are a collective of premium and prestige beauty brands committed to making beauty better and creating consumer love. People here are passionate, innovative, and thoughtful. This is an inspirational group of talented people, working together to build something better. We are looking for the best talent to join us on that journey. We believe we can accomplish more when we move as one. About The Role Assist in international registration of cosmetic products and ensure proper labeling of products for international marketing as well as ensuring the safety substantiation of formulas via formula review and toxicological assessment of ingredients per relevant EU guidelines and any US or international updates to guidelines for substantiating safety. Coordinate as necessary with the Technical Director and team to ensure data availability and timing as well as any certification documents for substantiating both safety and efficacy. Specifically manage notifications for the EU, UK and Middle East through our EU/UK Responsible Person (Biorius currently) and our distributor in the Middle East by providing necessary data, documentation, artwork, etc. for formal review and registration of products. Primary Duties & Responsibilities: Gather, generate and manage technical information including formula, raw material data, specifications, stability data, safety test report, efficacy test report, SDS, artworks, packaging material, ingredient listing, etc. Creation of detailed Cosmetic Product Safety Reports as required by EU regulations for products in the portfolio Assist in assessing incoming safety reports from the field to determine if there is a need to report the safety information to government agencies (e.g., US FDA) or to outside consultants/responsible parties (e.g. Biorius in Europe & UK). Assist in gathering, organizing, and delivering Regulatory information to product development, marketing, R&D, QA, manufacturing, contract manufacturer, and third-party partners. Preparation of submissions to necessary governmental registration forms/surveys as required on a timely basis, including, CA Safe Cosmetic Act notification, Canada Cosmetic Notification, EU/UK CPNP & REACH notifications, US OTC Registration. Ensure accuracy of outgoing Regulatory information and artwork Liaise between internal and external personnel at each stage of Regulatory compliance Preparation of detailed project reports as well as cosmetic product safety reports as assigned by management Working Relationships/Key Stakeholders: Product Development Marketing R&D QA/Technical Consumer Relations Manufacturing External Registration and Consulting Partners Governmental agencies Qualifications & Competencies: (List required or desired education; competencies; experiences; soft & hard skills) College graduate with strong organizational skills; preferably 1year in global cosmetic/OTC regulatory experience Must have excellent computer skills Highly motivated independent thinker with capacity to be flexible, find solutions, and make effective decisions Detail-oriented with excellent communication skills BS or BA Toxicology, Biology, Chemistry or related field Desire to complete EU Safety Assessor training course if deemed appropriate by management. What Orveon Offers You You're a creator of Orveon's success and your own. This is a rare opportunity to share your voice and accelerate your career in a demanding and fun environment. We're a lean organization and so your work will have a big impact and you'll have easy access to senior leaders. We invest in Orveoners to support their success through training, online learning and career opportunities. Benefits Orveoners take care of Orveoners. People who work hard deserve great recognition, along with benefits that fit their personal needs of individuals, including: “Hybrid First” office environment with drinks, snacks and regular social events “Work From Anywhere” 6 weeks a year Free Product Regular wellness and speaker events Other things to know! Pay Transparency - One of our values is Stark Honesty and the following represents a good faith estimate of the compensation range for this position. The range for this opportunity is: $55,000 $70,000 At Orveon Global, we carefully consider a wide range of non-discriminatory factors when determining salary. Actual salaries will vary depending on factors including but not limited to location, education, experience, and qualifications. Opportunities and Accommodations - Orveon is deeply committed to building a workplace and global community where inclusion is not only valued but prioritized. Find out more on our careers page. BE AWARE OF FRAUD! Please be aware of potentially fraudulent job postings or suspicious recruiter activity by persons that are posing as Orveon Global Recruiters/HR. Please confirm that the person you are working with has ******************** email address. Additionally, Orveon Global does NOT request financial information or payments from candidates at any point during the hiring process. If you suspect fraudulent activity, please visit the Orveon Global Careers Site at *********************************** to verify the posting and apply though our secure online portal.