Senior Regulatory Specialist

  • Salary: Up to £55,000 per annum
  • REF Number: 00048523
  • Consultant: Naynesh Mistry
  • Contact: 01246 457722
  • Date Published: 10.07.2020
  • Closed Date: 06.08.2020
  • Sector: Medical Devices, Life Sciences, Diagnostics
  • Location: Abingdon, Oxon/Wilts
  • Discipline: Regulatory Affairs, Qa/Validation, Biotechnology

CK Science are currently recruiting for a Senior Regulatory Specialist to join a global Biotechnology company based in Abingdon on a permanent basis. The successful candidate will lead and support all Pre and Post Market activities for IVD and Medical Device products

Salary: On offer is a competitive salary plus benefits (pension, life assurance and 25 days holiday plus bank holidays).

The Role: Responsibilities of the Senior Regulatory Specialist:

  • Provide regulatory support and guidance for all regulated products (Pre and Post Market).
  • Maintain and update technical files for product modifications.
  • Compile and publish all material required for submissions, license renewals, and annual registrations.
  • Provide input to global registration and device listing.

Your Background:

  • Bachelor's Degree in related field.
  • Commercial experience (minimum five years) in Regulatory Affairs within the IVD or Medical Device industry.
  • Understanding of new IVDR and MDR requirements.
  • Understanding of US regulatory pathways such as 510(k)'s or PMA.
  • Experience in foreign regulations and dossiers compilations including US submissions (HIGHLY DESIRABLE).

Apply: For more information or to apply for this Senior Regulatory Specialist position, please contact Naynesh Mistry on 01246 457722 or email, quoting job ref 48523.

It is essential that applicants hold entitlement to work in the UK.


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