Medical Device Auditor

2 days ago


Wakefield, Wakefield, United Kingdom TÜV SÜD Full time
Job Title: MHS Lead Auditor

Join TÜV SÜD America, Inc. as a Medical and Health Services (MHS) Lead Auditor and take on a challenging role in ensuring the compliance of medical devices with regulatory requirements.

Key Responsibilities:
  • Perform medical device audits in accordance with applicable regulations and standards, including Medical Device Regulations (IVDR, MDR), Medical Device Single Audit Program (MDSAP), and international quality system standards (e.g. ISO 13485, ISO 14971).
  • Conduct file reviews of regulatory submissions, including product-specific Technical Documentation assessments and Design Dossier reviews.
  • Provide project management for NAFTA-based customers, facilitating the issuance of quotes and coordinating with other TÜV SÜD America personnel to handle audit projects and client requests.
  • Identify and coordinate audit teams, communicate effectively with internal and external customers, and provide information on international standards and regulatory requirements.
Requirements:
  • Master's degree or foreign equivalent in Bioengineering, Regulatory Science, Project Management, or a related field.
  • 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.
  • At least 1 year of experience with quality management-related activities, such as design control, process/product/method validation, design transfer, risk management, manufacturing controls, or QC testing.

TÜV SÜD America, Inc. is an Equal Opportunity Employer.



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