Senior Regulatory Affairs Associate

Principle RA

Ref: 84| Posted: 17th Apr 2023

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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