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Job Details

Quality and Regulatory Specialist

Company: EPM Scientific
Location: Düsseldorf
Reference: QRS2- RNMR
Closing Date: 22 Mar 18
Type: Permanent
Salary (£): 40,000 - 60,000

Job Summary:

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...


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. 


  • 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 


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


  • 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 here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: or phone +442037588934

Apply for this job: Quality and Regulatory Specialist

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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