Medical Device Review Specialist

8 hours ago


Canada Life Science People Full time
Technical File Reviewer Opportunity

The Life Science People team is seeking a skilled Technical File Reviewer to join our team. As a Technical Certifier, you will be responsible for conducting thorough technical file reviews for Medical Devices, ensuring compliance with current regulations and device standards.

Key Responsibilities:

  • Conduct technical file reviews for Medical Devices
  • Ensure technical files align with current regulations and device standards
  • Project Management responsibilities with multiple client-facing reviewing tasks
  • Maintain up-to-date knowledge of current MDD/MDR changes and implement where necessary
  • Communicate effectively with fellow team members to ensure a thorough understanding of technical reviews
  • Customer-facing role requiring professionalism throughout the review process
  • Consultative responsibilities when delivering technical file feedback to clients

Requirements:

  • Bachelor's degree in Life Sciences, Medical, or related fields
  • 4+ years of experience in the Active Device field (manufacturing, auditing, research & development)
  • Must come from an Active Device and/or Medical Software background
  • ISO 13485, ISO 14971, 21 CFR 820, MDR knowledge (MDSAP preferred but not required)
  • Must have Notified Body experience
  • Fluent in English

About the Company:

Life Science People offers a remote opportunity, excellent career progression, and a chance to work with a leading Notified Body.



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