New · posted Nov 5
Regeneron · Biotechnology
Director, Medical Device Quality Assurance
- East Greenbush, NY
- On-site
- Full-time
- Director
The role
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.
What you need
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.
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.
What you'll do
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.
Pay and benefits
$175,700 – $292,700 a year
Employer provided$175,700.00 - $292,700.00
Annual bonuses
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
East Greenbush, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in East Greenbush, NYWorking conditions
When & where
- Location: East Greenbush, New York, United States
- Work schedule: Monday-Friday, 8am-4:30pm
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in the US60 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $175,700 | — | $292,700 |
| All US (middle half) | $186,375 | $219,500 | $241,000 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 348 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership4
- Quality systems and risk2
- GMP and compliance1
- Lab testing and methods1
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
Company hiring pulse
Regeneron on Regulatory Jobs
- 172
- Open roles
- 147
- Distinct roles
- 11
- Locations
By discipline
- Quality72 42%
- Clinical71 41%
- Regulatory29 17%
By level
- Associate & Specialist55 32%
- Director51 30%
- Manager51 30%
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Director, Medical Device Quality Assurance at Regeneron
Open until filled. $176K–$293K a year, employer provided.