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Global Regulatory Manager

  • Job type: Permanent
  • Location: Bremen
  • Salary: Competitive
  • Job reference: RNMR - 222RM
  • Sector: EPM Scientific, Regulatory
  • Date posted: 01/03/2018
Global Regulatory Affairs Manager

A global leading manufacturer of hardware medical devices is looking for a global regulatory affairs manager to provide regulatory strategy and implement it at a national and international level. The team has received strong investment recently as it oversees changes in preparation for the MDR. The successful candidate will join with a 3 month embedding period, during which they'll be educated with practical work experience on all markets they are unfamiliar with. This will include education on FDA, LAPAC OR any other geographical locations that they've not yet successfully registered devices in. 

Company Overview

The companies portfolio is strictly medical device, covering software and hardware. They develop and manufacture across 4 key continents - Europe, North America, South America and Asia. Their primary product area is medical imagine software, but they also focus on diagnostic devices, surgical devices and other non-software devices. They are looking to grow a strong and stable team and as a result, they are funding full training and education on underdeveloped regulatory skill sets. They are open to people without ISO 62304, or IEC 60601 experience, as long as the successful candidate is open to learning.  

Responsibilities:
  • You will provide and implement regulatory strategy on a global level. 
  • You maintain the regulatory portfolio of specific product groups, with a focus on worldwide registrations and a later chance to develop specialisms in product types. 
  • Perform global regulatory registrations (FDA, EU, China, Japan, Brazil)
  • Be responsible for an change management or other regulatory activities 
  • Monitor global approval strategies 
 

Requirements:
  • Bachelor’s degree in physical/biological sciences or engineering preferred
  • Expertise in standards and regulations for medical devices as ISO 13485, IEC 62304, IEC 62366, ISO 14971, CFR Part 820
  • Experience with Regulatory Affairs for medical device
  • Fluent German
 

Package:
  • Competitive benefits and great personal development opportunities
  • Home office 
  • Great atmosphere within a vibrant international team
  • A modern and creative working environment
  • Insight into cutting-edge technologies for the successful development of diagnostics and medical devices
 

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.a33ho1gmptb@epmscientific.aptrack.co.uk or phone +442037588934
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