Job Description
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:
1. Create and contribute to regulatory strategies for new products and design changes to existing products.
2. 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.
3. Support the creation and maintenance of Clinical Evaluation Report(s).
4. Collate and submit Technical Files to the Notified Body and respond to questions as required.
5. Support the Post Market Surveillance process.
6. Support the maintenance of Risk Management files.
7. Act as RA reviewer/appro...