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(Senior) Regulatory Affairs Manager

  • Location

    Kleinostheim

  • Sector:

    Quality, Regulatory Affairs

  • Salary:

    80,000 - 90,000EUR

  • Contact:

    Rebecca Stevens

  • Job ref:

    23390

(Senior) Regulatory Affairs Manager

Interested in joining a company who are leaders in the ophthalmic field?

Want to be a part of a collaborative team and work with a diverse portfolio of medical devices?

We're currently supporting a client in the medical device industry who are head-quartered on the outskirts of Frankfurt and are looking to strengthen their Regulatory Affairs function. Their focus is within the ophthalmic field and they are producing Class Is-IIb medical devices (including sterile, software, hardware and laser technology).

* This is a hybrid position, so you must be accessible to the site.
 

Focuses:

  • Overseeing product registrations in international markets e.g. China, Korea, FDA

  • The creation and maintenance of technical documentation

  • Support with successful entrance of products into international markets

  • Providing support during internal and external audits

  • Communication with regulatory authorities

  • Supporting with testing laboratory activities  

 

Experience required:

  • Knowledge of ISO 13485 and experience with IEC 60601 is desirable

  • 4+ years of experience within Regulatory Affairs

  • Fluency in English and German

 

If you're interested in this position, please contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com #LI-HB1 #LI-Hybrid