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.
Senior Regulatory Affairs Specialist – Remote
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 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.
Senior Development Quality Engineer – Based in Scotland with some home working
Reporting to the LumiraDx Development Quality Engineer Manager, the successful candidate shall be responsible for the quality and regulatory activities associated with IVD assays and Quality Controls through the design and development, verification and validation, transfer to manufacturing and release and post market phases.
The candidate shall work with project teams to support in the design and development process and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development lifecycle. The candidate shall be required to work cross-functionally with other teams to ensure that all aspects of the LumiraDx Platform are being considered throughout the development and manage these effectively. The candidate shall undertake line management responsibilities for Development Quality Engineers within the team, when appropriate, to ensure that alignment is maintained within the Assay Development Quality Engineer team.
About You
We are looking for highly motivated individuals with exceptional attention to detail and high level of skills in communication, along with experience working to standards such as ISO13485 and FDA 21CFR Part 820. We are looking for skills in the development and writing of technical files, adverse event reporting, supporting design and development and verification and validation.
We also have other vacancies at various levels across QARA. Please see our website for more details and to apply:
