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Regulatory Affairs Specialist

  • Job type: Permanent
  • Location: Bonn
  • Salary: Competitive
  • Job reference: BY-2018-LR
  • Sector: EPM Scientific, Regulatory
  • Date posted: 26/03/2018
Regulatory Affairs Specialist

A global leading manufacturer of medical devices and hygiene products is seeking a Regulatory Affairs Specialist, required for in Bonn, Germany. The Regulatory Affairs Specialist will be a part of a team of 10 regulatory professionals, reporting directly to the Head of Regulatory Affairs. 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 used for negative pressure wound therapy, ophthalmology, Dermatology, and Orthotics. As a result, they are requiring people who have experience with ISO 13485. They have 15 manufacturing sites across the globe and the products are distributed internationally.

Responsibilities:

- You routinely plan, coordinate and check the documentation of medical devices according to internationally recognized regulatory requirements.
- Interdisciplinary projects guide you expertly and also advise our specialist departments (Marketing, R & D and Purchasing) competently on the interpretation and implementation of regulatory requirements.
- Keeping them up-to-date ensures that they are complied with, continuously monitor changes and develop viable registration strategies.

Requirements:

- University degree with a scientific or medical technical focus
- Several years of experience in the international registration of medical devices as well as in the   regulatory documentation and the respective submission procedure
- Experience with approvals in the Asian region is an advantage
- Fluent English and German, another foreign language is an advantage

Package:

- Competitive market salary
- Training and career development
- 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.a33ho1gnbng@epmscientific.aptrack.co.uk or phone +442036678354.
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