Work From Home - Regulatory Affairs Manager / PPRC

  • Sector:

    Regulatory Affairs

  • Contact:

    Hollie Dear

  • Contact email:

    Hollie.Dear@adaptivelifescience.com

Work From Home - Regulatory Affairs Manager / PPRC

Are you a Regulatory Affairs Manager, searching for the next step in your career? Interested in joining a team who are driven by innovation?

We're currently supporting a client in the medical device industry who are searching for a Deputy PRRC to help strengthen their Regulatory Affairs function. They are producing devices in respiratory and anaesthesia technology, with plenty of further innovation in the pipeline.

This role can be based remotely (within Germany), with some travel to the HQ in Northern Germany.

Focuses:

  • Creation and maintenance of technical documentation

  • Monitoring, evaluation, and implementation of regulatory requirements

  • Supporting with successful entrance of product into national and international markets (product registrations)

  • Providing support during internal and external audits

  • Implementing new regulatory requirements in the Quality Management System

  • Supporting with Post Market Surveillance activities

  • Advising on regulatory topics, in collaboration with development and quality management teams

Experience required:

  • Knowledge of ISO 13485 and applicable standards

  • 2+ years of experience within Regulatory Affairs for medical devices

  • Previous experience with Post Market Surveillance is desirable

  • 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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