16 days old

Regulatory Affairs Specialist (m/f/d) in Stargard (Poland)

Danaher
Stargard, Woj. Zachodniopomorskie

PURPOSE OF POSITION

For our RA International Registration team (in Russia, Kazakhstan, Denmark and Poland) we are looking for a new colleague for the position as Regulatory Affairs Specialist for Radiometer Group. You will have a dotted line to QA Director in Poland and a direct line to RA team manager in Denmark. You will be responsible for ensuring regulatory inputs for production within Radiometer´s different product areas such as Immunoassays, Transcutaneous Monitors, Samplers, IT Solutions and the Blood Gas products.

RESPONSIBLITIES

  • Working with international registrations, process improvements, regulatory maintenance and lifecycle
  • Supporting production projects and the ongoing implementation of EU IVDR/MDR regulation (European In Vitro and Medical Device Regulations)
  • International registration by compiling of dossiers to obtain approvals worldwide
  • Legislation monitoring and being able to translate this and implement this in Radiometer
  • Maintain market approvals and current documents within responsibility area
  • Support to cross-functional projects
  • Participate in process improvements and creation of SOP´s in the RA area (SOP €“ Standard Operating Procedure)
  • Compile, submit and support on International Registrations.
  • Sign statements related to international registrations
  • Availability to travel from Poland to Denmark (Radiometer headquarter)

    REQUIREMENTS FOR THE POSITION

    KNOWLEDGE/EXPERIENCE

    • Higher education: preferable in Science, engineering, pharmacy, biology or similar
    • Minimum of 2 years€™ experience  preferably in the Medical Device industry
    • Proven knowledge in compiling regulatory files and achieving approvals worldwide
    • Ideally  experienced with worldwide regulatory submissions and knowledge of international regulatory legislation
    • International experience, ideally used to collaborate with different cultures
    • Project-minded, has experience with project management and cross functional projects
    • Proven experience in similar roles as  project manager or project participant
    • Knowledge in Quality management systems, knowledge of issues related to medical devices/in vitro diagnostic medical devices, technical documentation and regulations related to the  FDA, 21 CFR Part 820, e.g. ISO 13485
    • Language skills: English and Polish €“ both at fluent level

      PERSONALITY:

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Posted: 2020-05-21 Expires: 2020-06-20

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Regulatory Affairs Specialist (m/f/d) in Stargard (Poland)

Danaher
Stargard, Woj. Zachodniopomorskie

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