Regulatory Affairs Specialist, 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 fast lab solutions, 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
Regulatory Affairs Specialist, US - this role can be based remotely in the US - ideal location would be around the Waltham, MA area
- The Regulatory Affairs Specialist is expected to work both independently and with managerial oversight 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.
- The Regulatory Affairs Specialist 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 role may also support global regulatory submissions.
Key Roles and Responsibilities
- 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.
- Review labeling, marketing/promotional materials, and other documents for regulatory compliance as needed.
- Review proposed design changes for existing products.
- 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 regulatory interactions, including pre-submission teleconferences or face to face meetings, as well as responses to regulatory inspections and regulatory submission review inquires.
- Work collaboratively with internal project teams and stakeholders to proactively manage details related to current EUA products and future products.
- Prepare and present updates to management and key stakeholders.
- Support the creation and/or optimization of systems, processes, and procedures as required.
- Support other US post-market regulatory activities as required, including adverse event monitoring and reporting.
- Bachelor’s Degree in physical or life science
- Previous regulatory or quality experience in medical devices, preferably in IVD
- Advanced degree in a medical, scientific or technical discipline.
- Formal training in regulatory affairs with RAC certification highly desirable.
- Significant 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 reviewing design change control documentation
- Excellent writing and document editing ability
- 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 and protection of human research participants
- Highly proficient with Microsoft Office, database tools and telecommunication tools.
- Excellent written and oral communication skills.
- Highly organized with strong attention to detail.
- Ability to work in a complex, face-paced environment.
- Action-oriented and ttentive to deadlines.
For further information and to apply for this role, please click APPLY