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UK Head of Regulatory Affairs

4 months ago

England, United Kingdom Kinetica UK Ltd Full time
Search our vacancies within the Life Science, MedTech and Healthcare sectors below.

Head of Regulatory Affairs – Yorkshire/ UK / Hybrid – Medical Device

About the Company:

We are looking for a Head of RA or RA Manager from the medical device industry to join a specialist medical device company. This role will ensure regulatory compliance across UK sites and will be responsible for managing teams.

Responsibilities:

  • Ensuring all medical devices comply with relevant regulations in the relevant geographical areas.
  • Maintaining and updating technical files.
  • Ensuring all technical documents are current and accurate.
  • Ensuring EU declarations of conformity are current and accurate.
  • Obtaining regulatory approvals.
  • Leading regulatory parts of audits and inspections.
  • Maintaining device listings and performing facility registrations.
  • Performing change notifications.
  • Maintaining and requesting CFG’s and CFS’s.
  • Acting as onsite expert in regulatory matters.
  • Providing regulatory guidance for UK sites and when needed, globally.
  • Ensuring the responsibilities of EU Authorised Representative are fulfilled and no audit observations.
  • Timely release of products for sale.
  • Approval and maintenance of all product registrations.

  Requirements:

  • Degree in a relevant Scientific or Engineering discipline or law.
  • Significant RA experience in the medical device industry up to class IIb.
  • Experience managing a team.
  • Experience of 510k submissions.
  • Experience effectively managing and developing staff.
  • Experience with MDSAP would be beneficial.

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