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Regulatory compliance manager entry level jobs - 7 jobs
Medical Device Regulatory Affairs Strategist
Oracle
Columbus, OH
**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.$78.5k-128.5k yearly 60d+ agoRisk and Compliance Manager
Community Health Centers of Greater Dayton
Dayton, OH
This position is responsible for identifying, implementing, monitoring, and evaluating the overall risk management and corporate compliance plans at Community Health Centers of Greater Dayton (CHCGD). This position works collaboratively with all disciplines to establish a safety culture, emphasizing clinical risk, patient safety, visitor, third party, volunteer, and employee safety, as well as potential business, operational, and property risks. Manages and monitors the CHCGD s compliance and Risk Management effort, reporting identified issues directly to the Chief Executive Officer. Risk Management Create Risk Management training plan for staff based on quarterly safety checks, incident report trends, observations by management team, annual OSHA and Compliance requirements, and other identified needs. Maintain and update the CHCGD Risk Management Plan and ensure alignment with strategic goals. Oversee or conduct risk assessments, walk through inspections, adverse event reports, past accreditation or licensing surveys, medical records, risk analysis methods to identify, evaluate, prevent and control the risk of injury or loss. Identify, assess and mitigate clinical, operational, financial and reputational risks across the organization. Report on Risk Management activities to the Risk Management Committee. Prepare the quarterly and annual QA/Risk Management reports for the Board. Coordinate submission of annual FTCA malpractice application Oversee incident reporting and patient complaints and participate in root-cause analysis of occurrences or possible occurrences. Participate in HRSA reporting and site visits. Coordinate Disaster Management and Preparedness activities Oversee the Respiratory Protection Plan and implementation. Compliance Develop, implement and maintain a comprehensive compliance program in accordance with HRSA, OIG, OSHA, FTCA and other regulatory requirements. Serve at CHCGD s designated compliance officer. Assists Quality Coordination, Operations staff and the Executive Management Team in the review, revision and formulation of appropriate policies and procedures to guide issues of compliance. Assures compliance of federal, state, and local laws, as well as the HRSA Compliance Program. Conduct regular compliance risk assessments and audits: develop corrective action plans as needed. Participate in HRSA reporting and site visits. Ensure ongoing compliance with CHCGD s Corporate Compliance Plan Monitor and interpret changes in healthcare laws, regulations, and guidelines and update policies and procedures accordingly. Management Manage the Clinical Training Program Lead the implementation of the infection control plan as well as respond to implementation questions from managers. Assist with and/or conduct EHR/PM system training for staff and providers. Coordinate the Clinical and EHR Training of staff (Manages Staff Development Specialist activities) Qualifications, Skills, and Abilities Working knowledge of Risk Management and Compliance processes. In-depth knowledge of HRSA, FTCA, HIPAA, CMS and other relevant regulations. Demonstrate initiative, ability to work with others and good professional judgment. Able to work independently and organize time effectively. Excellent written and verbal communication skills. Strong organizational skills and attention to detail. Able to work with confidential information. Proficiency in MS Office products, such as Word, Excel, Power Point and Outlook. Working knowledge of EHR Coaching, mentoring, and teaching skills. Ability to relate well to people from diverse ethnic and cultural backgrounds. Motivate and inspire others by setting a positive example, solicit and/or provide innovative ideas from staff, co-workers, and physicians. Open to feedback for improvement, willingness to change, and be flexible. Required Knowledge, Licensure/Registration Graduate of LPN or Registered Nursing program with current licensure or related healthcare degree preferred; BSN preferred. Current CPR certification is required. Ambulatory, CHC or primary care experience preferred. Familiar with standard concepts, practices, and procedures within healthcare office setting. Previous experience with risk management and compliance required.$63k-91k yearly est. 41d agoRegulatory Affairs & Quality Manager at Eleeo Brands
North American Properties
Cincinnati, OH
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!$97k-155k yearly est. Auto-Apply 31d agoQuality Compliance Manager
Grifols Sa
Whitehall, OH
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Quality Systems & Training Manager Summary: Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. Include who they report to and what positions they have on the team. Education: Bachelor of Science degree or equivalent. Primary Responsibilities: ● Maintains oversight of the center's quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties. ● Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. ● Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files. ● Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained. ● Responsible for the personnel functions of the Quality Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks. ● Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required. ● Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations. ● Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. ● Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment. ● Performs a review of the documentation of unsuitable test results and unit lookback information. ● Performs a review of donor adverse event reports and the applicable related documentation. ● Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file. ● Performs employee training observations to ensure staff competency prior to releasing employees to work independently. ● Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance. ● Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities. ● Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues ● Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented. ● Holds monthly Quality Meeting to communicate status updates and manage action outcomes. #BiomatUSA Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : OH-Whitehall:USWHIPC - Whitehall OH-E Main St-BIO$76k-112k yearly est. 60d+ agoQuality Compliance Manager
Biomat USA, Inc.
Whitehall, OH
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Quality Systems & Training Manager** **Summary:** Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. Include who they report to and what positions they have on the team. **Education:** Bachelor of Science degree or equivalent. **Primary Responsibilities:** ● Maintains oversight of the center's quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties. ● Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. ● Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files. ● Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained. ● Responsible for the personnel functions of the Quality Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks. ● Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required. ● Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations. ● Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. ● Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. ● Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment. ● Performs a review of the documentation of unsuitable test results and unit lookback information. ● Performs a review of donor adverse event reports and the applicable related documentation. ● Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file. ● Performs employee training observations to ensure staff competency prior to releasing employees to work independently. ● Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance. ● Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities. ● Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues ● Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented. ● Holds monthly Quality Meeting to communicate status updates and manage action outcomes. \#BiomatUSA Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : OH-Whitehall:USWHIPC - Whitehall OH-E Main St-BIO** Learn more about Grifols (************************************** **Req ID:** 536924 **Type:** Regular Full-Time **Job Category:** MANUFACTURING$74k-107k yearly est. 60d+ agoHealthcare Regulatory Compliance
Edwards Health Care Services, Inc.
Hudson, OH
GEMCORE's continued success has earned us national recognition with Inc. Magazine's list of America's Fastest-Growing Companies and with the Cleveland Plain Dealer as Top Workplace 6 years running! We are looking for qualified candidates who share our enthusiasm and drive for winning and want to be part of our caring culture! Are you looking for a role that is part of a key initiative that is vital for the growth of the organization? All the while allowing for work/life balance? Edwards Health Care Services, Inc., a division of GEMCORE is a well-established and growing healthcare distribution company specializing in highly efficient distribution through its nationwide wholesale, retail, and pharmacy divisions. We are seeking a highly motivated Healthcare Regulatory Compliance person to join our high energy, friendly team. The Regulatory Compliance's main responsibility is to assist in the successful administration of the Corporate Compliance Program. This role is vital in working closely with our growing Pharmacy in ensuring compliance with outside accrediting organizations, as well as state/federal licensing organizations. We offer growth opportunities with potential for advancement This position is an in-office position located in Hudson, OH Schedule is 8:15 am - 5:00 pm, Monday through Friday Employer paid vacation Benefits available included medical/dental/vision, life, short and long-term disability insurances, and 401K Retirement Savings Plan Ongoing training and development Key Responsibilities: Research federal and state regulatory requirements for the distribution of medical devices. Process state and federal license applications to ensure medical device license requirements compliance. Assists in the implementation and monitoring of compliance controls, compliance procedures and operational processes. Conducts timely filings of reporting and renewal activity with licensing and regulatory agencies for Wholesale Distributor, DME and Pharmacy. Maintain database and create electronic records of company contracts, licenses and agreements. Inquires and responds to designated regulatory and accreditation agencies. Maintains working knowledge of basic healthcare compliance legal and regulatory requirements. Research regulatory changes that impact standard operating procedures and standards. Be knowledgeable of the agencies, such as the state Pharmacy Boards, Departments of Health, Secretary of State offices, Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), and USPTO, that issue the licenses and credentials maintained by the company. Key requirements: High attention to detail and excellent organizational skills Strong reading comprehension ability Qualified candidates must have excellent written, and verbal communication skills. Demonstrated strong computer skills. Knowledge of Process Improvement concepts. Minimum 0-2 years of related experience in a consumer service or healthcare environment. Ability to multi-task with established time management skills. Bachelors' degree or equivalent experience. About GEMCORE GEMCORE, a family of companies headquartered in Hudson, Ohio - Edwards Health Care Services, GEMCO Medical, GemCare Wellness, and GEM Edwards Pharmacy - offers a core set of healthcare solutions by partnering with manufacturers, providers, employer groups, insurance groups, and patients to deliver high quality healthcare products and innovative services to proactively better lives. For more information, visit ********************** To learn more about this position and to view other openings, visit our career site: **************************************$28k-55k yearly est. 17d agoRisk and Compliance Manager
Community Health Centers of Greater Dayton
Dayton, OH
Job Description This position is responsible for identifying, implementing, monitoring, and evaluating the overall risk management and corporate compliance plans at Community Health Centers of Greater Dayton (CHCGD). This position works collaboratively with all disciplines to establish a safety culture, emphasizing clinical risk, patient safety, visitor, third party, volunteer, and employee safety, as well as potential business, operational, and property risks. Manages and monitors the CHCGD's compliance and Risk Management effort, reporting identified issues directly to the Chief Executive Officer. Risk Management Create Risk Management training plan for staff based on quarterly safety checks, incident report trends, observations by management team, annual OSHA and Compliance requirements, and other identified needs. Maintain and update the CHCGD Risk Management Plan and ensure alignment with strategic goals. Oversee or conduct risk assessments, walk through inspections, adverse event reports, past accreditation or licensing surveys, medical records, risk analysis methods to identify, evaluate, prevent and control the risk of injury or loss. Identify, assess and mitigate clinical, operational, financial and reputational risks across the organization. Report on Risk Management activities to the Risk Management Committee. Prepare the quarterly and annual QA/Risk Management reports for the Board. Coordinate submission of annual FTCA malpractice application Oversee incident reporting and patient complaints and participate in root-cause analysis of occurrences or possible occurrences. Participate in HRSA reporting and site visits. Coordinate Disaster Management and Preparedness activities Oversee the Respiratory Protection Plan and implementation. Compliance Develop, implement and maintain a comprehensive compliance program in accordance with HRSA, OIG, OSHA, FTCA and other regulatory requirements. Serve at CHCGD's designated compliance officer. Assists Quality Coordination, Operations staff and the Executive Management Team in the review, revision and formulation of appropriate policies and procedures to guide issues of compliance. Assures compliance of federal, state, and local laws, as well as the HRSA Compliance Program. Conduct regular compliance risk assessments and audits: develop corrective action plans as needed. Participate in HRSA reporting and site visits. Ensure ongoing compliance with CHCGD's Corporate Compliance Plan Monitor and interpret changes in healthcare laws, regulations, and guidelines and update policies and procedures accordingly. Management Manage the Clinical Training Program Lead the implementation of the infection control plan as well as respond to implementation questions from managers. Assist with and/or conduct EHR/PM system training for staff and providers. Coordinate the Clinical and EHR Training of staff (Manages Staff Development Specialist activities) Qualifications, Skills, and Abilities Working knowledge of Risk Management and Compliance processes. In-depth knowledge of HRSA, FTCA, HIPAA, CMS and other relevant regulations. Demonstrate initiative, ability to work with others and good professional judgment. Able to work independently and organize time effectively. Excellent written and verbal communication skills. Strong organizational skills and attention to detail. Able to work with confidential information. Proficiency in MS Office products, such as Word, Excel, Power Point and Outlook. Working knowledge of EHR Coaching, mentoring, and teaching skills. Ability to relate well to people from diverse ethnic and cultural backgrounds. Motivate and inspire others by setting a positive example, solicit and/or provide innovative ideas from staff, co-workers, and physicians. Open to feedback for improvement, willingness to change, and be flexible. Required Knowledge, Licensure/Registration Graduate of LPN or Registered Nursing program with current licensure or related healthcare degree preferred; BSN preferred. Current CPR certification is required. Ambulatory, CHC or primary care experience preferred. Familiar with standard concepts, practices, and procedures within healthcare office setting. Previous experience with risk management and compliance required.$63k-91k yearly est. 11d ago
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