UK Head of Regulatory Affairs

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.
Sales Associate – Gloucestershire – Medical Device About the Company:We are looking... Field Service Engineer – Field based/ South UK – Diagnostics About the Company:We a... Job Title: Operations Manager (Nurse Qualified) - Care HomesLocation: South of England... Job Title: Nursing Home ManagerKinetica is proud to collaborate with a care home grou... Technical Specialist – Cheshire/ Northwest UK – Diagnostics About the Company:We are ...CER Writer - Remote - Medical About the Company:We are looking for several experienced CER Wr...Job Title: Nursing Home ManagerKinetica is proud to collaborate with an expanding care home group i...Product Manager– Deeside/ Northwest UK – Diagnostics About the Company:We are looking for a m...Account ManagerLocation: Northeast US (Remote)About the Company:Kinetica has partnered with a lead... Maintenance Engineer – Cheshire – Diagnostics About the Company:We are looking for ...
#J-18808-Ljbffr