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Medical Device Review Specialist
2 months ago
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 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.
