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Regulatory Affairs Consultant

  • Job type: Permanent
  • Location: England
  • Salary: Competitive
  • Job reference: 404413/002_1555080818
  • Sector: Medical Affairs, EPM Scientific
  • Date posted: 12/04/2019

Description:

A leading medical device consultancy is in search of permanent Regulatory Affairs Consultant, a Homebase position in Germany.

Your personal and professional development is important and a focal point for the organisation, and you can expect challenging work responsibilities, my client offers an attractive compensation package and exceptional career opportunities, while working with a high motivated international team.

Responsibilities:

  • Researching and advising classification and regulatory pathways

  • Submitting regulatory premarket submissions, technical files, communicating specific requirement for effective submissions

  • Preparing meeting requests between clients and FDA, and conducting those meeting

  • Supporting CE marking

  • Reviewing technical documentation and advising clients on how to make this more effective (Risk management, labelling, reports)

  • Travel 30-40%

Skills and Experience Required

  • German language skills (Business Fluent)

  • Experience with other regulatory documents/submissions (US: 513(g), Pre-Subs, IDE;

  • Canada: Class II-IV MDLs; EU: CERs).

  • Hands on experience with US 510K submissions

  • EU Technical files and knowledge of CE Marking

  • Clinical evaluation report writing

  • Quality assurance background experience

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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