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Regulatory Affairs Supervisor/ Manager

From £50,000 to £55,000 per annum
Harris Lord Recruitment Limited

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Title: Regulatory Affairs Supervisor/ Manager

Location: Bucks (commutable from London via M40)

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 Supervisor/ Manager.

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
o Attention to detail

A competitive salary is on offer plus 1 day working from home per week and more benefits.

This job was originally posted as www.totaljobs.com/job/91092392

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