Regulatory Affairs Team Lead - Glasgow, United Kingdom - FPSG

FPSG
FPSG
Verified Company
Glasgow, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

FPSG are delighted to be retained on a search for a full-time Regulatory Affairs team lead to join our key client based in Glasgow.

This role is responsible for leading the compliance team with in this medical device organisation.


JOB REQUIREMENTS

  • Preparation of regulatory documentation and submissions for product approvals
  • Development of regulatory plans/strategies for new products and changes to existing products
  • Participation in Design Control, Risk Management activities
  • Production and review of design dossiers, technical files and change assessments including custom made devices
  • Review and preparation of regulatory paperwork in accordance with International standards and new regulations
  • Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations

QUALIFICATIONS & EXPERIENCE
***- Experience in team/ project management/ custom made devices is desired

  • Experience with quality engineering and/or MDR is required
  • Able to communicate with external parties: Customers, Distributors,
  • Able to communicate with personnel in QA/R&D and other departments
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