Regulatory Affairs Specialist

  • Location

    Hamburg

  • Sector:

    Regulatory Affairs

  • Contact:

    Luke Fines

  • Contact email:

    Luke.Fines@Adaptivelifescience.com

Regulatory Affairs Specialist

Location: Hamburg Metropolitan Region (Hybrid) – 60% Home Office

Overview:
Our client offers a wide range of medical diagnostics products and solutions to assist healthcare professionals throughout the world in illuminating the path with diagnostics. They combine highly durable, multi-functional, and user-friendly devices with a variety of reagents and software, dependable service, and support in the domains of haematology, urinalysis, haemostasis, life science, flow cytometry, crucial healthcare, and now immunochemistry.

Benefits:

  • As a family-friendly business, they support flexible working hours, provide a care allowance for children, and have a parent-child space on our grounds. They also promote innovative work in a global setting while maintaining a family atmosphere.

  • Capital-forming benefits and subsidy towards the company pension plan

  • Flexible working hours and the option of mobile working

  • Subsidy towards the public transportation "ProfiTicket," free parking for all employees

  • Diverse selection of sport courses in our own fitness studio and massages

  • Canteen/free beverages/fruit

  • 30 days annual holidays as well as Christmas and holiday bonus

Tasks:

  • Assist our partners in registering our products in the EMEA region

  • Coordination and preparation of registration submissions

  • Keep records of registration and archive them

  • Develop expertise in any regulatory requirement that is relevant to our products and make sure that the organisation is informed of any new or modified regulations

  • Facilitate the submission of tender offers (regulatory documentation)

Your Profile:

  • You hold a university degree in biomedical sciences or equivalent

  • You have at least one year of practical experience in the medical device technology industry, preferably in a regulatory affairs or clinical affairs function

  • Experience working with either MDR/IVDR/FDA preferred

  • You gained experience in working with government officials and distributors

  • Ideally, you also have basic knowledge of RoHS and REACH regulations

  • Your command of written and spoken English is excellent

    

To apply or for more information please contact Luke via email on: luke.fines@adaptivelifescience.com

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