Senior Manager Quality Assurance, Medical Device; Sustaining

Overview

Regeneron is 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 of an engineer and quality specialists. The role is Monday‑Friday, 8am‑4:30pm at East Greenbush, New York, United States.

• 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.

• 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.

• 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.

• B.S. in Engineering and 8+ years of experience, including combination product or medical device experience, or an equivalent combination of education and experience.
• Previous supervisory/people leadership experience.
• Knowledge of the combination device development and lifecycle process.

Annual salary range: $ – $ (U.S. location).

Regeneron offers a competitive and comprehensive total rewards package that may include bonuses or incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, disability), paid time off, and family support benefits.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.