Sr. Manager, Medical Device Quality Assurance

Responsibilities

• 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
• Advice 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
• This role requires:
• B.S 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
• Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
• For jobs in Canada: this posting is for an existing position.
• Salary Range (annually)
• $126,300.00 - $206,100.00

Benefits

Additional Information

Build our future together: Regeneron is currently seeking a Senior Manager, Medical Device Quality Assurance (QA) to join our Medical Device QA team. This expanded leadership role will provide QA oversight across two critical functions: Combination Products Sustaining Engineering and Compliance. The position will lead a team engineer and quality specialists. When & where: Monday-Friday, 8am-4:30pm Location: East Greenbush, New York, United States

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