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Quality and Regulatory Specialist

  • Job type: Permanent
  • Location: Düsseldorf
  • Salary: Competitive
  • Job reference: QRS2- RNMR
  • Sector: EPM Scientific, Quality
  • Date posted: 08/03/2018
Quality and Regulatory Affairs Specialist 

An international leader in medical imaging devices is searching for a quality and regulatory affairs specialist for their site in Bonn. Germany. The quality and regulatory affairs specialist will join a team of 4 quality and regulatory specialists and will be reporting into the Head of Quality and Regulatory Affairs. The successful candidate will be responsible for ensuring compliance of medical devices for quality and regulatory. You will be challenged with the responsibility of QA/RA representative for development projects and international registration activities. 

Company Overview

The company is a global leader in medical imaging devices, with manufacturing and distribution facilities throughout EMEA and the Americas, Asia and Australia. They develop and both medical devices and medical products for global distribution, and they focus on provided research centres and hospitals with equipment and products that allows for affordable healthcare. Their mission is to engage the world with healthcare and allow everyone, from all walks of life, to be diagnosed and treated affordably. 


Responsibilities:
  • Develop and implement Regulatory Strategies for assigned projects/products
  • Ensure quality compliance and support continual improvement of quality management system
  • Cross-functional QA/RA representative for development projects across Europe 
  • Assurance compliance to ISO 14971 and ISO 13485 
  • Internal auditing and representation of pre-registration actions for external audits 
  • Control of pre and post-market design processes 

Requirements:
  • Experience with medical device regulatory affairs 
  • Experience with medical device quality 
  • Experience with ISO 13485 
  • Experience with ISO 14971
  • Fluent German and English 

Package:

  • Competitive market salary 
  • Exposure to wide range of medical products and medical devices 
  • Exposure to international regulatory experience 
  • Work in the city center of Duesseldorf

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.a33ho1gmw3o@epmscientific.aptrack.co.uk or phone +442037588934
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