Regulatory Affairs Manager – Diabetes Care (on-site)
Core
Lead U.S. regulatory strategy and lifecycle management for Abbott's Libre continuous glucose monitoring portfolio, ensuring FDA compliance and timely market entry.
Role type
Senior Regulatory Affairs Manager (Medical Devices)
Builds
FDA-approved medical devices (glucose sensors) for patients with diabetes
Domain
Healthcare / Medical Devices / Diabetes Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
U.S. regulatory strategy, FDA submission management (510k, PMA), team leadership, cross-functional partnership, compliance excellence, risk assessment, SOP development, stakeholder negotiation
Preferred skills
Master's or Ph.D. in science/engineering, RAC certification, Class II/III device experience, post-approval change management, international regulatory knowledge (EU MDR)
Technologies
FDA submission systems, regulatory databases
Responsibilities
Drive U.S. regulatory strategy for new product and lifecycle management; Lead and mentor a team of regulatory professionals; Partner cross-functionally with R&D, clinical, quality, and commercial teams; Drive and provide strategic guidance on FDA pathways, submissions, and interactions; Negotiate and interact with regulatory authorities during the development and review process; Ensure compliance excellence, balancing speed to market with robust regulatory standards
Seniority
Senior, hands-on IC with team leadership
