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Senior Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Stuttgart
  • Salary: Competitive
  • Job reference: RNMR - 29991
  • Sector: EPM Scientific, Regulatory
  • Date posted: 03/04/2018
Global Regulatory Affairs Manager

The global leader in high-risk cardiovascular implantable devices is looking for senior regulatory affairs manager to provide and implement regulatory strategy across key geographical markets. The senior regulatory affairs manager will join the team near Stuttgart, Germany and be directly responsible for 3 regulatory affairs specialists. The whole team currently consists of 12 regulatory affairs specialists/managers, 1 regulatory affairs director and 1 head of regulatory affairs. This position is to be reporting to the director of regulatory affairs. The senior regulatory affairs manager will oversee strategic and operational activities that allow the company to maintain their leading position in global cardiovascular devices markets, including Europe (EU), USA, Japan, China, Australia, and others.


Company Overview

The company leads the way in their market - cardiovascular devices. This is true on a global, international and regional scale. Their innovative technologies and high-quality devices integrate patient-focused design with state-of-the-art research facilities. Above all, the company encourages innovation and the hierarchy of the team allows things to be challenged, and questions to be asked. Despite their global dominance, you will have a voice and you are encouraged to openly share your ideas to promote innovation. 


Responsibilities:
  • Develop, provide and revise regulatory strategies on local, national, international and global levels. 
  • Implement regulatory strategies in team-lead function to strengthen the companies market-leading position. 
  • Perform operational duties for highest risk devices in order to obtain country registrations in EU and Rest of World (ROW) countries. 
  • Direct management of 3 regulatory affairs specialists, you will be responsible for growing out the team further in coming months. 
  • Responsible for whole product life-cycle management for high-risk devices. 

Requirements:
  • BSc in life sciences OR Dipl. Engineering.
  • Strong experiences with ISO 13485, ISO 14971.
  • Strong experiences with regulatory affairs for medical devices, preferably with high-risk medical devices (not essential).
  • Experience with registrations of products in EU, and preferably other countries. 
  • Fluent German, strong level of English. 
 

Package:
  • Work with the global leader in their market
  • Work with complex, high-risk medical devices 
  • Work for well established, international company with great benefits package.
  • Work near Stuttgart
  • Great atmosphere within a very international team
  • 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.a33ho1gnhir@epmscientific.aptrack.co.uk or phone +442037588934
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