Senior Specialist Regulatory Affairs
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 Specialist - Regulatory Affairs (This role can be remotely based across the US)
The Senior Specialist, Regulatory Affairs will be responsible for supporting US FDA regulatory submissions from the development of regulatory strategy through the submission of EUA, 510(k), and PMA packages to FDA for emergency use authorization, clearance, or approval of LumiraDx products.
The Senior Specialist, Regulatory Affairs is expected to work independently to provide regulatory expertise across multiple products in a global, fast-paced organization. The candidate will prepare regulatory submission packages and ensure compliance with all requirements. The candidate will also support important strategic activities by researching applicable regulatory requirements and test performance metrics. The candidate may also support global regulatory efforts. Expected to identify and resolve routine issues and problems, while proactively defining and escalating non-routine issues.
- Support activities associated with FDA Emergency Use Authorization, 510(k) clearance, and/or PMA approval of in vitro diagnostic (IVD) medical devices.
- Write, prepare, edit, and review FDA submissions for new and existing IVD products.
- Create new templates for regulatory submissions when required.
- Review clinical and analytical protocols and reports for regulatory content.
- Develop regulatory strategies for product submissions.
- Create and maintain regulatory filing repository as required.
- Publish electronic regulatory filings, ship final packages to regulatory agencies.
- Collaborate with subject matter experts in various functional groups to compile necessary submission materials.
- Support and eventually lead regulatory interactions, including pre-submission teleconferences or face-to-face meetings, as well as responses to regulatory inspections and regulatory submission review inquires.
- Review labelling, marketing/promotional materials, and other documents for regulatory compliance as needed.
- Prepare and present regular updates to management and key stakeholders.
- Other duties, as assigned.
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:
- Bachelor’s Degree in physical or life science and regulatory experience, preferably in IVD or medical devices
- You will ideally have previous experience in 510(k) and PMA submissions within IVD or medical devices
- Experience managing multiple regulatory submissions simultaneously
- Ability to build positive, productive and proactive relationships with a range of internal and external key stakeholders
- Be self-driven, take ownership and demonstrate high levels of personal accountability; be motivated to complete the goals and objectives
- Be able to listen and present effectively, providing progress updates and feedback on a regular basis
- Demonstrate your ability to solve problems under conditions of uncertainty and ambiguity
For further information and to apply for this role, please click APPLY