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 nmistry@ckscience.co.uk, quoting job ref 48523.

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

INDGEN

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