Regulatory Affairs Manager – Diabetes Care (on-site)

What You’ll Do

• Drive U.S. regulatory strategy for new product and lifecycle management.
• Lead and mentor a team of regulatory professionals, fostering a culture of collaboration, development, and high performance.
• Partner cross-functionally with R&D, clinical, quality, and commercial teams to influence product development and ensure regulatory success.
• Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
• Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.
• Ensure compliance excellence, balancing speed to market with robust regulatory standards.
• Anticipate and effectively communicate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with cross-functional teams.
• Execute and manage technical and scientific regulatory activities.
• Must function independently as a decisionmaker on regulatory issues and assure that deadlines are met.
• Develop, enhance and streamline regulatory policies, processes and SOPs and train team members.
• Evaluate regulatory risks of division policies, processes, procedures.
• Stay ahead of evolving regulatory requirements, guidance, and industry trends.
• Interpret and implement changes to SOPs and submission documentation as required.

Required Qualifications

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience
• Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Note : Higher education may compensate for years of experience.
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
• Domestic and international regulatory guidelines, policies and regulations.
• Lead functional groups in the development of relevant data to complete a regulatory submission.

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Master’s or Ph.D. in a technical area.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions.
• Experience with Class II and Class III medical devices.
• Able to define regulatory strategy.
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Experience with post-approval manufacturing and design changes.
• Able to lead or mentor a team of regulatory affairs professionals.
• Able to work effectively on cross-functional teams and build strong relationships with key stakeholders.
• Strong attention to detail with a solution-orientated mindset.
• Able to juggle multiple and competing priorities.
• Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.
• Uses in-depth knowledge of business functions and cross group dependencies/ relationships.

Pay

The base pay for this position is $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted.