Job Title: Regulatory Affairs Specialist (Contractor) – Medical Devices
Job Type: 9 Month Contract
Location: UK based, fully remote
We are partnered with a growing medical device manufacturer who are requiring a regulatory contractor on a 9 month basis. This is an urgent position and ideally is looking for the right person to start immediately.
Responsible for the creation, update and maintenance of all technical files in support of obtaining and maintaining Notified Body CE certification, FDA clearance, and UKCA marking. As well as Post Market Surveillance activities.
Job Responsibilities include;
- Contribute to regulatory strategies for new products and design changes to existing products.
- Create and maintain, Technical Files including the Summary Technical Documentation and GSPR Checklists for the UK, Europe, and MDSAP countries as well as 510(k) submissions.
- Implement the transition of certain product types to EU MDR 2017/745 (ensuring technical documentation is compliant and up to date).
- Support the creation and maintenance of Clinical Evaluation Report(s).
- Collate Technical Files for submission to the Notified Body, and contribute to responses to questions as required.
- Coordinate the Post Market Surveillance process for Summit's range of products.
- 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 RA-specific support during external audits as required.
- Provide and present RA related data for reports and presentations, including Management Review.
- Complete internal audits as assigned (pending completion of appropriate training).
- Contribute to departmental and company objectives/KPIs.
- Provide RA training and support to other team members/colleagues as required.
Candidate Requirements include;
- Minimum of five 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 essential.
If this position is of interest to you please forward your up-to-date CV to
The role does not offer Sponsorship.