Medical Device Audit Lead

4 weeks ago


Wakefield, Wakefield, United Kingdom TÜV SÜD Full time

Medical Device Audit Lead

Job Summary:

The Medical Device Audit Lead will perform medical device audits in accordance with applicable regulations and standards. This role requires a strong understanding of medical device regulations, quality management systems, and auditing principles.

Key Responsibilities:

  • Audit medical devices to ensure compliance with regulations and standards
  • Develop and implement audit plans to ensure effective and efficient audits
  • Conduct file reviews to evaluate regulatory submissions and technical documentation
  • Provide project management for NAFTA-based customers
  • Coordinate with other TÜV SÜD 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.



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