Principal Regulatory Affairs Specialist - this role can be remote based across the USA
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.
The Principal Regulatory Affairs Specialist – Instrumentation and Software (North America) provides strong expertise and experience for the LumiraDx North American RA team in point of care IVD instrumentation and software. Reporting to the VP RA/QA (North America), the successful candidate will work collaboratively with both the North American and International RA/QA management teams as well as necessary external stakeholders.
The role will be responsible for supporting US FDA regulatory submissions from the development of regulatory strategy through the submission of emergency use authorization (EUA), 510(k), and PMA packages to FDA for EUA, clearance, or approval of LumiraDx products. The candidate will also provide expertise to supporting design change control review and strategy for new and existing products. The role may also support global regulatory submissions. The role will act as a subject matter expert in the area of point of care IVD instrumentation and software.
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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