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Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Bremen
  • Salary: Competitive
  • Job reference: RNMR - 12433
  • Sector: EPM Scientific, Regulatory
  • Date posted: 26/03/2018
Regulatory Affairs Manager

In Bremen, a leading dental medical device organisation is seeking an experienced regulatory affairs manager for their production/manufacturing site. This Regulatory Affairs Manager will join the international regulatory affairs team, and be involved in the building out of the regulatory affairs team for international registration of medical devices. Working with a multifunctional project team, including a head of QA, a head of RA and 3 RA managers, you will report to the head of regulatory affairs. The regulatory affairs manager will coordinate and execute all international regulatory activities and strategies for dental devices team, including CE-marking and FDA approvals, post-market activities and the growth of the RA team.

Company Overview

The company is a respected member of the dental device world, specialising in delivering innovative solutions that integrate state-of-the-art technology into affordable healthcare options. They also offer various add-ons and accessories, providing an impressive and diverse range of devices. The company prides itself on the quality of their devices and their contribution to affordable healthcare.  

Responsibilities:
  • Register and re-certify products for the international medical device market
  • Whole product lifecycle approval review
  • Provide regulatory strategy and preview existing international strategies
  • Responsible for communication with Notified Bodies
  • Update relevant teams with international alterations to international approval regulations
  • Responsible for growth and training of new and existing regulatory staff

Requirements:
  • Bachelor’s degree in science or technical subject
  • Experience with medical device regulatory affairs (dental preferred but not essential)
  • ISO 13485 & MDD/MDR experience 
  • Ability to plan and deliver on tasks and exhibit accountability 
  • Strong communication strong

Package:
  • Competitive salary and package
  • Work in the city of Bremen
  • Family business with international client base and innovative technologies 
  • A modern and creative working environment
 
Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact apply.a33ho1gncev@epmscientific.aptrack.co.uk or phone +442037588934
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