About this role
About the Role Senior Manager, Medical Device Quality Assurance will provide QA oversight across two critical functions: Combination Products Sustaining Engineering and Compliance. This expanded leadership role will lead a team of engineers and quality specialists. What You'll Do
- Manage, mentor, and develop quality engineering and compliance teams
- Standardize, streamline, and improve processes across sustaining and compliance
- Implement digital, data-driven tools for accurate, consistent, and timely reporting
- Lead teams through complex, ambiguous challenges in a pharmaceutical/medical device environment
- Sustaining Engineering Support:
- Support sustaining engineering programs through risk assessment, design change management, and maintenance of the Design History File and Risk Management File
- Advise and actively participate in Design Reviews associated with combination products
- Provide QA and technical support to quality engineers and project teams during ongoing maintenance of the combination product
- Interact with partners and contract organizations to ensure accurate completion of project milestones, including post-commercialization activities
- Combination Product Support:
- Act as Management Representative for the combination products QMS; own policies and procedures
- Support regulatory inspections and partner audits for combination products
- Keep the QMS current and inspection-ready via monitoring, gap assessments, and updates What We're Looking For
- BS in Engineering and 8+ years of experience; including combination product or medical device experience; or equivalent combination of education & experience
- Previous supervisory/people leadership experience
- Knowledge of the combination device development and lifecycle process Compensation & Benefits
- Salary Range (annually): $126,300 - $206,100
- Benefits and total rewards may include annual bonuses or other incentive plans, equity awards, pension/retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life and disability), paid time off, and family support benefits
- For U.S. roles, Regeneron offers a competitive total rewards package; location-specific information provided during recruitment