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Senior Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Germany
  • Salary: Competitive
  • Job reference: 381093/005_1555079960
  • Sector: Medical Affairs, EPM Scientific
  • Date posted: 12/04/2019

Description:

A leading medical device consultancy is in search of Regulatory Affairs Manager located in the North of Germany.

The organisation seeks to offer services for all regulatory affairs and process optimisation of quality management and quality systems. As a company, with over 30 years of experience, they excel within all regulatory and normative issues regarding the approval of medical device, quickly and efficiently.

Responsibilities:

  • Risk Analysis
  • Complementation and supporting customers
  • Dealing with conformity of assessment of Medical Devices
  • Verification and Validation
  • Technical Documentation according to the ISO 13485
  • Travelling to clients

Skills and Experience Required

  • Engineering Degree
  • A strong technical understanding
  • Fluent in English and German B2
  • 3+ years of Regulatory Affairs in Medical Devices
  • Implementation of ISO 13485 and 21 CFR 820 (FDA)
  • Implantation of EN14971
  • Experience in dealing with a Notified Body
  • Project management and moderation skills

How to apply

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 +44 203758 8904

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