Principal Regulatory Affairs Specialist
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
Principal Regulatory Affairs Specialist - this role can be remote based across the USA
The Principal Regulatory Affairs Specialist 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 individual will also provide post-market support in terms of reviewing design change control and associated regulatory notifications and submissions. The role may also support global regulatory submissions. The Regulatory Affairs Lead will act as a subject matter expert in the area of Infectious Disease and/or Clinical Chemistry IVDs.
The Principal Regulatory Affairs Specialist (North America) provides strong expertise and experience for the LumiraDx North American RA team in either Infectious Disease or Clinical Chemistry IVD products. Reporting to the VP RA/QA (North America), the Principal Regulatory Affairs Specialist (North America) will work collaboratively with both the North American and International RA/QA management teams as well as necessary external stakeholders.
- Responsible for managing and creating timely, right first-time regulatory submissions and updates to submissions as well as timely and accurate responses to questions from regulatory authorities (North America)
- Support premarket RA activities (design assurance input) and oversee creation of regulatory files directly and in collaboration with the LumiraDx global regulatory team
- The primary responsibility of this role will be as an expert individual contributor, but may eventually involve the management of lower-level regulatory team members
- Participate in International RA assignments as directed by the VP RA/QA (North America) and under the guidance of the International RA/QA Team Lead
- Embraces a culture of proactive collaborative partnership and accountability.
- Support VP leadership to collaborate with key stakeholders in the development of regulatory strategies for new and existing products
- Provide expertise and serve as internal subject matter expert on regulatory requirements, current regulatory landscape and forthcoming regulatory changes
- Support the training and interpretation of regulatory requirements to all company associates within RA organization and other functional teams as needed
- Responsible for setting and achieving team goals and metrics in line with Global RA/QA expectations
- Support regulatory change controls and re-registrations, including relevant internal NTFs, special 510ks, PMA notifications, MDR, annual summary reporting and Health Canada updates as required
- Support regulatory responsibility for post-market activities including reviewing design change control proposals, supporting field actions, and ensuring that regions follow the appropriate post market surveillance, complaints, adverse incident reporting and vigilance processes
- Develop and maintain external relationships with key opinion leaders and regulatory officials
- Support regulatory interactions, including pre-submission teleconferences or face to face meetings, as well as responses to regulatory inspections and regulatory submission review inquires
- Review and approve regulatory submissions and promotional materials for compliance with North American regulations
- Provide regulatory leadership for due diligence activities, partnering activities and product/company integrations
- Support process improvement, harmonization, and simplification efforts to lead and advance continuous improvement culture
- Build strong relationships with internal and external customers to build, enhance, and ensure regulatory/quality assurance awareness
- Support VP leadership for determining significant regulatory changes that may impact current compliance status and/or represent significant business risk
- Contribute to development of budget and staff performance goals/metrics
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
- Extensive experience in regulatory or quality experience in IVD, ideally point of care
- Previous experience preparing EUA, 510(k), and/or PMA submissions for IVD devices
- Previous experience in either Infectious Disease or Clinical Chemistry as a focused discipline (e.g., molecular diagnostics, immunoassay)
For further information and to apply for this role, please click APPLY