Quality Assurance and Regulatory Affairs Assistant

Role: Quality Assurance and Regulatory Affairs Assistant

Salary: Extremely competitive basic salary plus annual bonus

Location: Based in Herefordshire

Our client, a leading global Medical Device company, is currently seeking a Quality Assurance and Regulatory Affairs Assistant to join the team.

This is a fantastic opportunity to join an extremely successful and forward thinking company, with fantastic opportunities for career development.

Key skills required:

  • Excellent writing skills
  • Computer literate & experienced in Microsoft Office applications – required
  • Ability to demonstrate ownership and accountability
  • Ability to plan, execute, control, and deliver
  • Strong communication skills both written and verbal
  • Strong attention to detail
  • Self-motivated
  • Knowledge of ISO 13485
  • Scientific knowledge and experience working with healthcare products
  • Knowledge of MDR 2017/745
  • Degree educated

Key responsibilities:

  • QMS Document Control and maintenance
  • Inspecting, verifying and maintaining compliance documentation
  • Developing strong working relationship with key stakeholders, including the Quality System, Supply Chain and Design & Development teams
  • Keeping up to date with key business, regulatory and industry developments and any changes to procedures and practices
  • Maintain up to date compliance documentation.
  • Keep up to date with current medical device guidelines, legislation and publications, assessing the impact of changes to the organisation

If you have the necessary skills and experience and are looking for an exciting new challenge, please apply to Westcott Search

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