We are currently looking to fill a Manager, Medical Device Quality Assurance position on our Medical Device Sustaining Engineering QA team. This position will provide QA oversight of the Medical Device function including combination products, including pre-filled syringe and auto-injectors/pen injectors for biological therapeutics developed internally and in collaboration with partners and CMO’s. Supports the work using quality risk management principles and their application to medical device development and commercialization. The scope will involve collaboration with internal and external partners, primarily post-transfer and commercial activities.
In this role, a typical day might include the following:
Provide leadership to team, including sustaining engineering support.
Support sustaining engineering programs through risk evaluation, design change, and maintain the design history file
Advise and participate in Design Reviews associated with combination products and/ or medical devices
Maintain the quality risk management file for commercial combination products within Regeneron including data driven risk assessments (risk identification, analysis and ranking)
Provide QA oversight and support to combination products in the sustainability phase of commercialization
Provide technical support to quality engineers and regulatory team during maintenance of the combination product
Responsible for the management and development of quality engineering team members
Represent Regeneron’s medical device QMS during regulatory inspections and partner audits
Interact with partners and contract organizations to ensure accurate completion of project achievements, including impact of changes and post-commercialization activities
This role may be for you if you:
Thrive in a quality focused environment
Have proven experience in global applications of Quality Assurance and Quality Risk Management in the medical device/combination products field
Possess excellent written, oral, and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences
To be considered for this role you must hold a Bachelors degree in Mechanical or Biomedical engineering or equivalent with the following amount of related experience in the pharmaceutical/medical device/biotechnology industry:
Associate Manager – 6+ years
Manager – 7+ years
Level is determined based on qualifications relevant to the role.
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.
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At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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