Compliance

• Prepare and update technical documentation for medical devices in accordance with MDR 2017/745
• Ensure compliance with applicable regulatory requirements
• Develop test plans, organize testing procedures, and define test characteristics and test setups
• Prepare standard test reports to demonstrate conformity with relevant standards
• Serve as the primary contact for Notified Bodies during technical documentation reviews and for regulatory inquiries from development and production teams
• Define regulatory strategies for medical device approvals

Regulatory Affairs Manager – Medical Devices

Regulatory Affairs Manager – Medical Device