Regulatory Affairs Specialist

Job Title:Regulatory Affairs Specialist – Medical Devices

Job Type:Permanent, full-time position

Location:Bourton on the Water, Gloucestershire, UK – (Hybrid)

Remuneration:Up to £40,000

An exciting Regulatory Affairs Specialist position working for a global leader in the provision of quality medical products. The role will involve working across a wide product portfolio, including orthopedic products.

The role will be responsible for the creation, update and maintenance of all technical files. Support obtaining and maintaining Notified Body CE certification, FDA clearance, and UKCA marking.

The role of RA Specialist has the following responsibilities:

• Create and contribute to regulatory strategies for new products and design changes to existing products.
• Create, maintain, and manage Technical Files including the Summary Technical Documentation and GSPR Checklists for the UK, Europe, and MDSAP countries as well as managing 510(k) submissions.
• Support the creation and maintenance of Clinical Evaluation Report(s).
• Collate and submit Technical Files to the Notified Body and respond to questions as required.
• Support the Post Market Surveillance process.
• Support the maintenance of Risk Management files.
• Act as RA reviewer/approver for product labelling, packaging artwork, and marketing materials.
• Assist in the interpretation of standard, regulatory and customer requirements for implementation in the QMS.
• Provide support during external audits.
• Provide and present data for reports and presentations.
• Contribute to departmental objectives/KPIs.
• Provide training and support to other team members/colleagues as required.

Experience/Qualification required:

• Minimum of three years’ experience in Medical Devices Regulatory Affairs.
• A degree or relevant experience in Life Sciences is desirable.
• Excellent working knowledge of Microsoft Office (including Word, Excel, and OneDrive).
• A practical understanding of Quality Management Systems is desirable.
• Project management skills are desirable.

This is a great opportunity to join a leading business who specialise in orthopedic products. Please note this is a hybrid position that will require 3 days on site per week.

For more information, please reach out to