Regulatory Affairs Manager – Diabetes Care (on-site)
$114,000–$228,000 year
On-site · Austin, Texas, United States or Milpitas, California, United States
Job Summary
Lead U.S. regulatory strategy for new product and lifecycle management in Abbott Diabetes Care, including guiding submissions (510(k), PMA) and pre-submissions; mentor and develop a team of regulatory professionals; partner with R&D, clinical, quality, and commercial teams to influence product development and ensure regulatory success; drive compliance and timely submissions while shaping policies and SOPs; independently resolve regulatory issues and communicate risks; frequent cross-functional collaboration with cross-functional teams and regulatory authorities; travel as needed (domestic) for regulatory activities.
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
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