Regulatory Affairs Specialist
Manor Loan, Stirling
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
- Creation and management of technical files of all legal manufactured products
- Creation of Quality Assurance/Regulatory Affairs 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
- Quality Management System updates required for higher risk In Vitro Diagnostics such as Premarket Approval and World Health Organisation pre-qualification programme activities.
- Review and approval of change requests for regulatory impact assessment
- Creation of process for the management of approval of global marketing collaterals and localization process
- Review and approval of marketing collaterals
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EEC/IVDR
- Development and writing of CE marking technical files
- Knowledge of Adverse event reporting in clinical environment
- Detailed knowledge of post market regulatory activities including Field Safety Corrective Actions, incident reporting
- Experience and knowledge of vertical and horizontal standards for IVD medical device instruments and assays in the point of care.
- Experience of working in an In Vitro Diagnostic or medical device design and manufacturing environment
- Strong communicator.
- Excellent organizational skills
- Demonstration of good problem solving abilities.
- Influence internal project team and external parties to maximize success opportunities.
For further information and to apply for this role, please click APPLY