Sr. Manager, Medical Device Quality Assurance at Regeneron

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

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
• 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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$126,300.00 - $206,100.00