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 currently has over 700 employees worldwide. 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.
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