2 weeks ago

Regulatory Affairs Specialist

Beaconsfield 35K - 45K Permanent

Title: Regulatory Affairs Specialist

Location: Beaconsfield - Bucks

My client is a reputable Medical Device Company; based in Buckinghamshire; and they have an exciting new opportunity to strengthen their team with a Regulatory Affairs Specialist.

Technical Specification

  • 5 years’ experience with MDD technical file writing and approval (Class 1, Class IIa, Class IIb)

Plus experience of as many of these additional items:

  • Implementation of PMCF plans
  • PMS data collection, analysis, reporting
  • Clinical Evaluation Report writing, review and update
  • Foreign market requirements: USA, Canada, Australia, Brazil, EU
  • Supporting regulatory aspects of MDSAP audits
  • Supporting Notified Body technical file assessments
  • MDR planning and implementation
  • Foreign market registrations worldwide (excluding; China, Russia, Japan, )
  • Regulatory input and activities for the design and development process
  • Working with or working as an Authorised Representative for MDD/MDR

Person Specification

  • Leadership of the Regulatory Team including developing junior team members
    • Supportive
    • Eager to share knowledge
    • Open with plans and tasks
    • Good delegation
  • Ownership of Regulatory outputs for the company
    • Planning; short and long term
    • Prioritisation of tasks and resource
  • Attention to detail

A competitive salary is on offer plus 2-3 days working from home per week and more benefits.

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