Regeneron · 2 weeks ago
Associate Manager, Medical Device Quality (Sustaining Engineering)
East Greenbush, NY
Full-time
Onsite
Mid, Senior Level
$91K/yr - $173K/yr
6+ years expRegeneron is a leading biotechnology company seeking an Associate Manager for their Medical Device Quality Assurance team. This role involves providing QA oversight for medical device functions, supporting sustaining engineering programs, and managing quality engineering team members while ensuring compliance with regulatory standards.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
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
Qualification
Required
Bachelors degree in Mechanical or Biomedical engineering or equivalent
6+ years of related experience in the pharmaceutical/medical device/biotechnology industry for Associate Manager
7+ years of related experience in the pharmaceutical/medical device/biotechnology industry for Manager
Proven experience in global applications of Quality Assurance and Quality Risk Management in the medical device/combination products field
Excellent written, oral, and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences
Benefits
Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off for eligible employees at all levels
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-08
2026-01-07
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