Terumo Aortic are looking for a Principal RA to join our team during an exciting time of growth and expansion for the business. This is a fantastic opportunity for someone to join our Regulatory Affairs team in a rewarding role with a company that offers career development amongst a host of excellent benefits.

The main responsibilities of the role are;

• Support RA representative during surveillance/ recertification 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, Design change evaluations, design reviews, CAPAs, SATs as required)
• 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
• Provide regulatory input to functional groups as required
• Perform Technical Documentation File reviews prior to submission for registrations
• Review of RA procedures for compliance
• Review and approve validation protocols and reports (e.g. site investment project)
• Facilitate in the compilation, communication and monitoring of FSN and recalls (if required)
• Other duties as required by RA department
• Review and sign off complaint reports
• Represent RA at Change review board as required

The successful candidate will possess;

• Min 5ys Regulatory and/or quality management experience within a medical device 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