Manager, Regulatory Affairs
Waltham, Massachusetts, US
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
You 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.
- 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 labeling, marketing/promotional materials, and other documents for regulatory compliance
- Prepare and present regular updates to management and key stakeholders.
You will be an experienced and motivated senior Regulatory Affairs professional with the following attributes:
- Advanced degree (Master’s Degree or higher) in physical or life science or an applicable regulatory field of study (in vitro diagnostics, medical device)
- Formal training in regulatory affairs with RAC certification highly desirable.
- 4+ years of professional regulatory experience with IVD devices, or other applicable area of physical or life science
- Previous experience with 510(k) and PMA submissions for point-of-care IVD devices
- Experience managing multiple regulatory submissions simultaneously
- Demonstrated problem solving ability
- Strong attention to detail and organizational skills
- Experience and interest in mentoring junior team members and manging direct reports
- Experience reviewing design change control documentation
- Excellent writing and document editing ability
- Proficient with Microsoft Office applications (Word, Powerpoint, Excel, etc)
- Demonstrated ability to meet project deadlines in a fast-paced startup environment
- Excellent time management skills and ability to prioritize multiple tasks
- Excellent interpersonal skills and demonstrated ability to collaborate with cross-functional teams
- Understanding of HIPAA nd protection of human research participants
For further information and to apply for this role, please click APPLY