Permanent
Regulatory Affairs
Inchinnan
Competitive + Benefits + Bonus

Team Leader - Regulatory Affairs

Ref: 22| Posted: 14th Nov 2022

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Terumo Aortic are looking for a Regulatory Affairs Team Leader 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.

Key Duties:-

  •  Preparation and review of regulatory documentation and submissions for product approval.
  • Development of regulatory plans/strategies for new products and changes to existing products.
  • Participation in Design Control, Risk Management and Post Market Surveillance activities.
  • Production and review of design dossiers, technical files and change assessments.
  • 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.
  • Facilitate compliance with Vigilance System.
  • Provide regulatory input to functional groups as required.
  • Participate in review of RA procedures.
  • Review and approval of validation, protocols and reports.
  • Mentorship of RA Associates.
  • Other duties as required by Regulatory Affairs department.

Qualifications & Experience:-

  • BSc Hons Degree or equivalent.
  • 3-5 years regulatory experience within a medical device environment is essential.