Regulatory Affairs Manager - Medical Devices (Contract)

Doncaster Temporary
  • Rapidly Expanding IVD Business
  • Leading and Managing a Regulatory Team

About Our Client

I have partnered with a medical technology company who specialise in developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. The company has major operations in the UK and the USA, and is supported by a global sales network.

Looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of the dynamic and forward-looking company.

Job Description

  • Management or regulatory dossiers of all legal manufactured products for pre and post market
  • Management and Creation of QA/RA plans for the design and development teams to support Global markets up to the formation of the standard dossier.
  • Creation and maintenance of harmonized standards compliance plans
  • Creation and maintenance of regulatory procedures to align with Global requirements
  • QMS updates required for higher risk IVD's such as PMA and WHO pre-qualification programme activities.
  • Review and approval of change requests for regulatory impact assessment
  • Management of regulatory process relating to marketing collaterals and country localization process
  • Review and approval of Labelling and marketing collaterals
  • Lead and manage a team of Regulatory Specialists working in pre and post market environment, including day to day activities to support the business in accordance with pipeline plans and non-routine activities as required by the business.
  • Support the training and development needs of the team
  • Provide training for other areas of the business on regulatory process and other compliance activities.

The Successful Applicant

  • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EC/IVDR.
  • Development and writing of CE marking technical files.
  • Knowledge of Clinical process.
  • Detailed knowledge of post market regulatory activities including FSCA, incident reporting.
  • Experience and knowledge of vertical and horizontal standards for IVD medical device instruments, software and assays in the point of care.
  • Experience of working in an IVD or medical device design and manufacturing environment.
  • Previous experience in people management

What's on Offer

Competitive Day Rate

Kelly Percival
Quote job ref
Phone number
+44 1727 730 143

Job summary

Contract type
Consultant name
Kelly Percival
Consultant phone
+44 1727 730 143
Job reference