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Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Brussels
  • Salary: Competitive
  • Job reference: RNMR - HLGI
  • Sector: EPM Scientific, Regulatory
  • Date posted: 26/01/2018
Regulatory Affairs Director

An global leader in medical device/IVD development is searching for a senior regulatory affairs specialist for their site in Brussels, who can make the step up from specialist to manager. The successful candidate will join an incredibly new regulatory team in the surgical devices division. They will be reporting into the regulatory affairs director and joining a regulatory compliance manager in developing and implementing regulatory strategies for approvals of IVDs across the EMEA region. This is an opportunity to provide strategic and technical expertise in regulatory affairs. The regulatory affairs manager will be responsible for CE -marking strategy and delivery. 


Company Overview

The company is an extremely successful US owned company who are looking to translate their success in over to the EU. They've dominated the women's healthcare diagnostics market for years. They out-compete other diagnostic manufacturers with their innovative and cutting edge technology. Due to their incredible product pipeline, they are investing heavily in regulatory affairs. Their products range from imaging devices to surgicle instruments. 

Responsibilities:
  • Develop and implement Regulatory Strategies for assigned projects/products
  • Responsible for IVD surgical devices across EMEA devices 
  • Provide regulatory support in the development process of surgical medical devices
  • Provide expertise in applicable regulations in order to identify and suggest potential strategies that can be used to address the gaps
  • Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies
  • Work together with the software development team and the image analysis team to define documentation strategy
  • Support implementation of device change in order to assess regulatory implications
 

Requirements:
  • Bachelor’s degree in physical/biological sciences or engineering preferred
  • Expertise in standards and regulations for medical devices as ISO 13485, ISO 14971, CE-marking
  • Experience with Regulatory Affairs for medical device AND/OR IVD software
  • Strong written and verbal English communication skills


Package:
  • Competitive benefits and great personal development opportunities
  • Work in the city centre of Brussels
  • Great atmosphere within a vibrant international team
  • A modern and creative working environment
  • Insight into cutting-edge technologies for the successful development of cancer therapies
 

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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