Director, Medical Device Quality Assurance

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Director, Quality Assurance position to join our QA Medical Device team. This role is responsible for leading the Medical Device Quality Assurance team, providing oversight of the Combination Products development for biological therapeutics developed in-house and in collaboration with partners and CMOs.

When & where:

• Location: East Greenbush, New York, United States
• Work schedule: Monday-Friday, 8am-4:30pm

Discover your role:

• Providing Quality Assurance oversight of the Medical Device / Combination Products function.
• Collaborates across the organization to provide development support.
• Develops strategies and processes to strengthen the integration of Combination Product development into the Regeneron organization.
• Creates resource plans to ensure adequate quality assurance support of combination product development projects, and other projects across the organization.
• Leads all aspects of the professional development of the Medical Device Quality Assurance team, including managers and engineers.
• Responsible for driving the department for optimal performance, reducing errors and improving efficiencies.
• Sets goals for the department to align with corporate quality assurance goals.
• Collaborates with internal collaborators, external partners, and agencies.

This role requires:

• BS/BA and 12+ years of experience in the medical device or combination product industry, or equivalent combination of education and experience.
• Understanding of applicable industry regulations, including 21CFR Part 4, 21 CFR Part 820, and ISO 13485.
• Demonstrated knowledge of combination product development requirements, specifically related to Design Controls
• Current knowledge and/or experience with QA systems such as CAPA, deviations, investigations, change control, etc.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

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.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$175,700.00 - $292,700.00