Connecting Talent to opportunity

Connecting Talent to opportunity

Senior Regulatory Affairs Specialist

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Job Description:

We are working with a global Medical Device company who, due to their exceptional continued growth, have an exciting opportunity for a Senior Regulatory Affairs Specialist to join the team in Berkshire.

As our new Senior Regulatory Affairs Specialist you will be working closely with the R&D Teams to lead RA activities on New Product Development projects whilst supporting changes for existing and pre-released products.

 This is a fantastic opportunity for an experienced Regulatory Affairs professional from the Medical Device sector with experience of Active Medical Devices

 Experience, Education and Knowledge Required:

  • Proven and demonstrable Regulatory Affairs experience
  • Sound knowledge of the regulatory framework for Medical Devices
  • Experience working with International Standards IEC/EN 60601-1/ 60601-1-2/ 62304/ 62366, ISO 14971 and ISO 13485
  • Good working knowledge of Design Control, Software Life Cycle, Risk Management, Validation & Verification processes

 

If you have the necessary skills and experience and want to join a company passionate about your progression, click apply now or call 01189 239 234 and ask for Kris Holmes.

 

 

  • Job Type

    Permanent, Full Time

  • Additional Salary Info

    Benefits

  • Work Authorisation

    United Kingdom

  • Industry Sector Engineering, Utilities
  • Years Experience

    2+ years

  • Career Level

    Experienced (Non-Manager)

  • Educational level

    Bachelor's Degree

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