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Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Brussels
  • Salary: Competitive
  • Job reference: RNMR - 9283
  • Sector: EPM Scientific, Regulatory
  • Date posted: 28/03/2018
Regulatory Affairs Manager

An award-winning global medical device and IVD company is seeking an experienced regulatory affairs specialist who can take the step up into a management position. Their title will be regulatory affairs manage, and they will be located at their site in Zaventem, Belgium. This Regulatory Affairs Manager will join the regulatory affairs department and be involved in the building out of the diagnostics team, working with a multifunctional project team that currently, consists of 1 regulatory affairs director, a junior regulatory affairs specialist and new regulatory and compliance manager. The Regulatory Affairs Manager will coordinate and execute all regulatory activities and strategies for the diagnostics devices, including CE-marking and other product registrations for EMEA, along with post-market activities and the growth of the RA team.

Company Overview

The company has an impressive and innovative range of products, that primarily focuses on the diagnosis and effective treatment for women's healthcare. The scope of this position is focused primarily on diagnostic devices. The company itself has a disproportionately large share of their market in the US, compared with their much larger diagnostics competitors. Due to exceptional market sales and impressive growth, they moved to the EU in 2013. Since Brexit, the company is now looking to set up a site outside of the UK and have opened up in Brussels. Hiring from the top-down, the company is now looking to find a senior regulatory specialist to report to the regulatory director. 

Responsibilities:
  • Be responsible for a small group (currently 1, growing) of regulatory affairs specialists.
  • Implement regulations for products registered or to be registered in EMEA markets. 
  • Monitor and define submissions targets for surgical submissions. 
  • Directly operate and perform regulatory submissions. 
  • Advise multiple departments (QA, R&D, Marketing etc.) on appropriate regulations and their implications. 
  • Contact person to notified bodies and regulatory agencies. 

Requirements:
  • Relevant experience with medical device/IVD regulatory affairs 
  • BSc in life sciences subject, or equivalent 
  • CE-marking of medical devices or IVDs is essential
  • Ability to use generally defined regulations to perform detailed registrations

Package:
  • Highly competitive salary 
  • Work in an innovative and leading global company
  • Work in Brussels, Belgium 
  • Work at the forefront of technologies that are saving patients lives
 

Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact jobs@epmscientific.com or phone +442037588934
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