Medical Device Audit Specialist
5 days ago
About the Role:
The Medical Device Lead Auditor will be responsible for conducting audits of medical devices in accordance with applicable regulations and standards. This includes auditing clients per Medical Device Regulations (IVDR, MDR), Medical Device Single Audit Program (MDSAP), and international quality system standards (e.g. ISO 13485, ISO 14971).
Key Responsibilities:
- Auditing: Perform regulatory audits of clients, reviewing and preparing reports and audit documentation for submission to the certification committee of the Notified Body.
- File Reviews: Evaluate regulatory submissions, including product-specific Technical Documentation assessments and Design Dossier reviews.
- Project Management: Provide project management for NAFTA-based customers, coordinating with other TÜV SÝ America personnel to handle audit projects and client requests.
Requirements:
A Master's degree in Bioengineering, Regulatory Science, Project Management, or a related field, plus 3 years of experience in an industrial medical device environment in Product Design, Product Development, or Manufacturing of IVD, Non-Active Medical Products, or Active Medical Products.
What We Offer:
Extensive domestic travel to client sites required; some international travel may be required. Based at HQ: 401 Edgewater Place, Suite 500, Wakefield, MA 01880; telecommuting is allowed pursuant to company policy.
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