Associate Manager, Quality Assurance (Medical Device)

Rensselaer, NY, United States
Jul 06, 2019
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Responsible to provide quality assurance oversight of medical device function focused on combination products including pre-filled syringe and auto-injectors/pen injectors for biological therapeutics developed in-house and in collaboration with partners and CMO's.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Manage the Medical Device Quality Management function ensuring compliance to all applicable medical device regulations.

• Manage a team of Quality Engineers in support of new product development.

• Provide guidance and participate where appropriate in Feasibility, Development, Design Verification, Design Validation, Design Transfer, and Commercialization reviews and activities from a quality and documentation perspective.

• Provides technical support to quality engineers and regulatory team for technical filings and updates.

• Interact with partners and contract organizations to ensure timely completion of project milestones.

• Approximately 20% travel.

Education and Experience:

• Requires BS, BASc, BEng in Mechanical, Biomedical engineering or equivalent with 6+ years industry experience in medical devices; delivery of parenteral drugs experience preferred.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.