Regulatory Affairs Specialist EU-MDR

Review of documentation and databases as Authorized Representative, Importer or Distributor according Regulation (EU) 2017/745. Support regional product registrations. Monitoring and implementation of applicable regulatory requirements.

Key Responsibilities

• Document review according (EU) 2017/745
• Registration support
• Support manufacturer for regulatory compliance

Qualifications

Scientific university degree or equivalent

Preferred Experience

Junior level in quality and/or regulatory affairs for medical devices.

Basic knowledge of regulatory requirements for medical devices (EU).