Senior Regulatory Affairs Specialist - this role can be remote based but with regular travel to our sites in Scotland
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.
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.
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:
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
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