Regulatory Affairs Manager – Diabetes Care (on-site)

Job Description

• Lead U.S. regulatory strategy, lifecycle management, FDA pathways, submissions, and regulatory-authority interactions for Abbott’s Libre diabetes-care portfolio.
• Manage, mentor, and develop regulatory affairs professionals while partnering with R&D, clinical, quality, and commercial teams.
• Drive compliance with domestic and international regulatory requirements, including FDA, 510(k), PMA, CE/EU MDR, and post-market activities.
• Require a bachelor’s degree or equivalent education/work experience and at least 4 years in a regulated industry; regulatory experience, medical-device experience, and RAC certification are preferred.
• On-site in Alameda or Milpitas, CA, or Austin, TX; full-time position paying $114,000–$228,000.