RA Specialist

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RA Specialist


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RA Specialist – Berlin

This is the opportunity to join a fast-growing MedTech company within their Regulatory team based in Berlin. You will be part of a young and experienced team working on international regulatory requirements for their high risk medical devices. This is an entry level position seeking a fast learning, ambitious individual with great training opportunities and exposure within the regulatory space.

You’ll be:

  • preparing and maintaining technical documentation for high risk medical devices.
  • communicating with international distributors and completing international registrations of medical devices.
  • multi-departmental support specifically with projects in the quality team regarding various quality aspects (CAPA, PMS, change control).
  • implementation of MDR requirements.

Candidate requirements:

  • BSc or MSc life sciences related discipline or regulatory affairs (advantageous).
  • First working experience within the Regulatory or Quality field.
  • Thorough knowledge of international approval procedures for the medical device industry.
  • Team player with excellent written and verbal communication skills.
  • Fluent in German and English.