UK Head of Regulatory Affairs

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 license renewals.
• 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.
• Excellent communication skills.
• Experience effectively managing and developing staff.
• Experience with MDSAP would be beneficial.