Regulatory Affairs Manager – Diabetes Care (on-site)
Core
Lead U.S. regulatory strategy and manage the regulatory lifecycle for Abbott's Libre continuous glucose monitoring portfolio.
Role type
Senior Regulatory Affairs Manager (Medical Devices)
Builds
FDA submissions (510(k), PMA) and market access for diabetes care products
Domain
Healthcare / Medical Devices / Diabetes Care
Required skills
U.S. regulatory strategy, FDA submission management (510k, PMA), team leadership, cross-functional partnership, compliance management, risk assessment, SOP development, stakeholder negotiation
Preferred skills
RAC certification, EU MDR experience, Class II/III device experience, post-approval change management, scientific data interpretation, mentoring
Technologies
FDA pathways, 510(k), PMA, IDE, EU MDR
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; Execute and manage technical and scientific regulatory activities; Develop, enhance and streamline regulatory policies, processes and SOPs
Seniority
Senior, hands-on IC with leadership responsibilities