Principal Regulatory Affairs

Are you an experienced Principal Regulatory Affairs Specialist looking for your next opportunity? Escape Recruitment are working with a leading manufacturer in the medical device industry, who are based just outside of Glasgow to recruit a PRA. You will join this team during a period of growth for the business, as well as joining an organisation which puts staff development at the core of the business, as well as offering an array of benefits.

**Responsibilities**:

- Support RA manager during surveillance/ re-certification audits (e.g. backroom, interviews etc as required)
- Lead and deliver regulatory projects (e.g. QMS consolidation, UDI, site investment, process improvements for RA and Custom device RA processes as required)
- Perform, review and sign off of technical documents (RnD) for Custom devices and CE devices including DTMs, risk management files, DCEs, design reviews, CAPAs, SATs as required) and lead and coordinate activities for RA CAPAs and SATs from initiation to closure (including initiation, investigation, reports, implementing action plan as required)
- represent RA and coordinate RA actions in business wide CAPAs, SATs and Supplier change notifications as required
- Perform Technical Documentation File reviews prior to submission for registrations
- Facilitate in the compilation, communication and monitoring of FSN and recalls (if required)
- Regulatory or quality management experience within a medical device or pharmaceutical environment is essential
- Able to communicate with external parties: Regulatory Authorities, Customers, Distributors, Notified Bodies, Competent Authorities
- Able to communicate with personnel in QA/R&D and other departments

If you would like to find out more information on this position, please hit 'apply' today.