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
Develop, enhance and streamline regulatory policies, processes and SOPs and train team members

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
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

Career development with an international company where you can grow the career you dream of
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
an affordable and convenient path to getting a bachelor’s degree
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

Regulatory Affairs Manager – Diabetes Care

Key skills