UK Head of Regulatory Affairs
4 weeks ago
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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