Senior Regulatory Affairs Specialist
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
Senior Regulatory Affairs Specialist - this role can be remote based but with regular travel to our sites in Scotland
Reporting to the LumiraDx Regulatory Manager, the successful candidate shall be responsible for the regulatory activities for the legal manufactured products associated with IVD medical devices (assays, instruments, software, and ancillary items relating to the system) development through the R&D phase and the verification and validation phase through launch and post-marketing arena. This role will be responsible for the management of regulatory administrative tasks and line management of junior regulatory specialists.
Activities such as requirements generation document/process creation, review and approval of documents and working with all project teams to guide the teams in the day-to-day development and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development.
- Creation and management of technical files of all legal manufactured products
- Creation of QA/RA plans for the design and development teams to support Global markets up to the formation of the standard dossier.
- Working closely with Development Quality Engineering team for core team activities and deliverables
- Creation and maintenance of harmonized standards compliance plans
- QMS updates required for higher-risk IVD’s such as PMA and WHO pre-qualification programme activities.
- Manage approval of change requests for regulatory impact assessment
- Manage process for the management of approval of global marketing collaterals and localization process
- Manage Review and approval of marketing collaterals by regulatory team
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in communication, along with the following skills and experience:
- 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 Adverse event reporting in a clinical environment
- Detailed knowledge of post-market regulatory activities including FSCA, 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 IVD 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