Regulatory Affairs Manager

  • Location

    Stuttgart

  • Sector:

    Regulatory Affairs

  • Salary:

    55,000EUR - 70,000EUR

  • Contact:

    Rebecca Stevens

  • Job ref:

    23631

Regulatory Affairs Manager
Are you a professional in RAQM, searching for a new challenge?

Would you enjoy having the flexibility to delve into new topics and learn new skills, working in a global regulatory affairs position?

We are supporting our client, a leading manufacturer in the ophthalmic field, in their search for a Regulatory Affairs Manager for their site in Stuttgart.

Focuses:
  • Creation and further development of national and international regulatory strategies
  • Handling communication with Notified Body and authorities, as well as suppliers (win relation to approval procedures)
  • Supporting with the maintenance of the post-market surveillance system
  • Preparation and maintenance of risk analysis and technical documentation
  • Updating of SOPs
  • Supporting the Quality Management function

Experience required:
  • A degree in the medical/engineering field
  • 2+ years of experience in Regulatory Affairs (within the healthcare/medical device sector)
  • Knowledge of regulatory requirements and medical device standards (e.g. ISO 13485 EU-MDR, ISO 14971)
  • Experience with the creation of technical documentation
  • Fluency in English and German

If you're interested in this position, please contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com
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