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Manager Medical Device Quality Assurance

Company Name:
Regeneron
Summary:
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 CMOs. Manage the Medical Device Quality Management System ensuring compliance to all applicable medical device regulations. 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.
Essential Duties and Responsibilities include, but are not limited to, the following:
Manage the Medical Device Quality Management System ensuring compliance to all applicable medical device regulations.
Provide guidance and participate where required 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.
Experience and Required Skills:
Education and Experience:
Requires BS, BASc, BEng in Mechanical, Biomedical engineering or equivalent with 8+ years industry experience in medical devices for delivery of parenteral drugs and specifically managing a Quality Assurance function responsible for ensuring compliance of Medical Device development and commercialization activities. Must have working knowledge and understanding of ISO13485. Previous leadership/management experience required. Approximately 30% travel.
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 Regenerons unwavering commitment to combining good science & good business.

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