- 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.
- 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