Technical Specialist

5 days ago


Canada Life Science People Full time
Job Summary

We are seeking a highly skilled Technical Specialist to join our team at Life Science People. As a Technical Specialist, you will be responsible for conducting technical file reviews for Medical Devices and ensuring that technical files align with current regulations and device standards.

Key Responsibilities
  • Conduct thorough technical file reviews for Medical Devices to ensure compliance with regulations and standards.
  • Project manage multiple client-facing reviewing tasks to ensure timely completion and high-quality results.
  • Stay up-to-date on current MDD/MDR changes and implement necessary updates to technical files.
  • Communicate effectively with team members to ensure a thorough understanding of technical reviews.
  • Provide consultative services to clients when delivering technical file feedback.
Requirements
  • Bachelor's degree in Life Sciences, Medical, or a related field.
  • 4+ years of experience in the Active Device field (manufacturing, auditing, research & development).
  • Must have experience in 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.
What We Offer
  • Working for a leading Notified Body.
  • Remote opportunity.
  • Excellent career progression opportunities.

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