Technical File Reviewer (Electronic Medical Devices)

• Competitve

Job Title: Technical File Reviewer (Electronic Medical Devices)

Salary: Competitive
Location: United Kingdom (Predominately Southern/Home Counties Region)
Job Type: Permanent
Benefits: Pension, Healthcare

Our client, a leading Notified Body, is seeking a Technical File Reviewer to join their Medical Device division in the UK. This is an exceptional opportunity to work with a dynamic team dedicated to ensuring the highest standards of quality and compliance in the electronic medical device industry.

Technical File Reviewer: Key Responsibilities:

• Review and assess technical documentation for electronic medical devices to ensure compliance with regulatory standards.
• Prepare detailed review reports and provide recommendations for improvements.
• Stay updated with regulatory changes and ensure review practices align with current standards.
• Collaborate with clients to address non-conformities and enhance their technical documentation.
• Provide training and mentorship to junior reviewers and support their professional development.

Technical File Reviewer: Experience and Qualifications Required:

• Extensive experience in reviewing technical files for electronic medical devices.
• In-depth knowledge of ISO 13485, IEC 60601 and other relevant regulatory standards.
• Software / IEC 62304 experience would be highly desirable
• Excellent communication and interpersonal skills.
• Ability to travel occasionally within the UK and internationally.

Apply to Lauren Park to learn more about this exciting opportunity or connect with me on LinkedIn for regular updates on job openings in the life sciences sector.