Senior Manager Quality Assurance, Medical Device (Sustaining)
Regeneron · Tech Valley
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-09-15). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Bachelor's degree in Engineering or equivalent education and experience
- 8+ years medical device or combination product experience
- Previous supervisory or people leadership experience
- Knowledge of combination device development and lifecycle processes
- Quality management system and regulatory compliance expertise
What you'll be doing
- Manage and mentor quality engineering and compliance teams
- Oversee sustaining engineering programs including risk assessment and design change management
- Act as Management Representative for combination products quality management system
- Support regulatory inspections and partner audits for combination products
- Implement data-driven tools for reporting and process improvement
Privacy & handoff
This role links to Regeneron's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.