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Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Tuttlingen
  • Salary: Competitive
  • Job reference: BY-2018
  • Sector: EPM Scientific, Regulatory
  • Date posted: 27/03/2018
Regulatory Affairs Manager

A global leading manufacturer for Medical devices is seeking for a Regulatory Affairs Manager, required for in Tuttlingen, Germany. The Regulatory Affairs Manager will be a part of a small team of 4 regulatory professionals, reporting directly to the Senior Regulatory Affairs Manager. Their devices range from Class I-III and contain both software and hardware. The company is looking for someone who can collaborate with other departments to ensure that the European, FDA and other applicable international regulations are complied.

Company Overview

This organisation is a manufacturer of hardware and software medical devices that are being distributed globally. The devices are optical imaging and surgical instruments. As a result, they are requiring people who have experience with ISO 13485. They have several manufacturing sites across Europe and the US and the products are distributed globally.

Responsibilities:
  • Supervision of international approval procedures
  • Advising on the development of new developments and changes regarding international approval
  • Monitoring and analysis of national and international developments in regulatory affairs
  • Collaboration in the maintenance of processes in the quality management system
Requirements:
  • Successfully completed engineering studies or a comparable qualification
  • 3-5 years of professional experience in the preparation of approval-relevant documents
  • Experience with approvals in the Asian region is an advantage
  • SAP knowledge
  • Experience in working on international projects
  • Fluent in English and German
Package:
  • Competitive benefits and great personal development opportunities
  • Insight into cutting-edge technologies for the successful development of optical imaging devices
  • A modern and creative working environment
  • 30 days holiday
  • Pension programme
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.a33ho1gncqr@epmscientific.aptrack.co.uk or phone +442036678354.
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