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Regulatory Affairs Specialist

  • Job type: Permanent
  • Location: Mannheim, Baden-Württemberg
  • Salary: Competitive
  • Job reference: 427903/002_1560164333
  • Sector: EPM Scientific, Regulatory
  • Date posted: 10/06/2019

Job Type: Regulatory Affairs Specialist
Location: Mannheim

A global leader in the innovative medical device industry, paving the way in discovering treatments for patients within the Ophthalmology industry, the organisation is seeking for a Regulatory Affairs Specialist to join their team. You can have a positive impact on the lives of millions of people around the globe, with the market of ophthalmology looking to surpass £27 Billion by 2023; the growth of products seem to be endless.

Key Responsibilities:

  • Identifying requirements for registrations and approval processes.

  • Conducting regulatory approvals for medical devices and ensuring that current regulatory approvals are maintained.

  • Processing International approvals for EU and USA.

  • Creating and maintaining important materials within marketing documentation.

  • Able to establish and explain in details how documents are processed.

Key Requirements Include:

  • Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.

  • 3/5 years' experience in Medical device.

  • Knowledge in marketing surveillance report.

  • Experience in writing product description.

  • Medical Device Background.

  • Experience within Technical Files.

  • Background knowledge in MDR Regulations.

Benefits:

  • Competitive benefits and great personal development opportunities.

  • Great atmosphere within a vibrant team.

  • Learning & Development Support.

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact Evan Shamma on +44 203 758 8904 or via email on

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