Regulatory Affairs Specialist (Registrations)

  • Location

    Norderstedt

  • Sector:

    Regulatory Affairs

  • Salary:

    €60,000

  • Contact:

    Luke Fines

  • Job ref:

    23472

Regulatory Affairs Specialist (Registrations Team) (f/m/x)

 

Location: Hamburg (Hybrid)

Overview:
Our client supports healthcare professionals around the world in lighting the way with diagnostics by providing a broad range of medical diagnostics products and solutions. In the fields of haematology, urinalysis, haemostasis, life science, flow cytometry, essential healthcare and now immunochemistry, they combine highly dependable, multi-functional and easy-to-operate instruments, a variety of reagents and software, plus reliable service and support.
 

Benefits:

  • A growing and healthy corporate group with respect and trust as the basis for cooperation and communication
  • As family friendly company we support flexible working time, offer a care allowance for children as well as a parent-child room at our premises
  • A family atmosphere as well as innovative working in an international environment
  • 30 days annual holidays as well as Christmas and holiday bonus
  • Capital-forming benefits and subsidy towards the company pension scheme
  • Flexible working times/flexitime as well as the possibility of mobile working
  • Subsidy towards the public transport “ProfiTicket”, free parking for all employees
  • Diverse range of sport courses in our own fitness studio and massages
  • Canteen/free beverages/fruit

Tasks:

  • Support our affiliates with the registration of our products in the EMEA region
  • Prepare and coordinate registration submissions
  • Archive and maintain registration documents
  • Develop proficiency in any applicable regulatory requirement that applies to our products and ensure communication of new or changed requirements within the organisation
  • Provide support to 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
  • 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
  • You are experienced in working with complex databases
  • Customer focus and results orientation, yet detail-oriented work style is what describes you

 

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

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