Regulatory Affairs Specialist

**About Us** At Prenuvo, we are on a mission to flip the paradigm from reactive "sick-care" to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience of our clinics across North America, have allowed us to lead the charge against "we caught it too late again." Prenuvo operates preventative screening clinics in Vancouver, Silicon Valley, Dallas, Boca Raton, Minneapolis, Los Angeles, New York City, Bethesda, and Chicago, with more clinics in North America and internationally in the next 2 years. **The Opportunity** We are changing healthcare and bringing a slow moving goliath of an industry into the present while blazing a trail into the future of radiology and clinical operations through software, automation and AI. We are looking for a **Regulatory Affairs Specialist** to support global pre and post market matters including regulatory submissions in all target jurisdictions as defined by our corporate strategy. Reporting to the Head of Regulatory Affairs & Quality, the Regulatory Affairs Specialist will support global pre and post market matters including regulatory submissions, medical device software design reviews, product releases, deviation management and change control activities, product promotional activities, labeling review activities, product registration and listing databases, global product registrations requests, and post market actions. The RA Specialist will ensure regulatory compliance of Prenuvo's product portfolio including SaMD/MDDS/CDS for advanced medical imaging technology and innovative AI/ML-enabled medical devices, in all target jurisdictions as defined by our corporate strategy. Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people's lives **_ Seize the opportunity to work in a role that offers the flexibility of remote work, with occasional travel to our vibrant headquarters in Vancouver._** **What You'll Do** **Regulatory Submissions**: - Prepare, submit, and update pre-submission packages, Q-sub/supplements/amendments & RA submission pathways compliant with 21CFR820, 21CFR892, and FDA guidance documents - Prepare justifications for intended use, risk classifications, and substantial equivalence matrix - Perform regulatory impact assessments of design changes **Documentation and Process Development**: - Collaborate with cross-functional teams to develop DHF/RMF/DMR alongside SaMD development sprints - Assist in developing eQMS processes, procedures, work instructions, and forms for the Regulatory department - Develop eQMS for DHF/RMF/DMR, cybersecurity, software development, and app development **Compliance and Auditing**: - Support front-room, desk audits, and site inspections by regulatory authorities - Review, comment on, and approve change control requests affecting medical device marketing - Complete letters to file following US FDA regulations and guidance **Relationship Building and Training**: - Build and nurture relationships with external authorities, including US FDA, Health Canada, and Notified Bodies - Complete all required training and maintain training plans and records **Regional Regulatory Affairs**: - Complete regional regulatory authority requests and provide requested documents - Review, comment on, and approve labeling change requests, advertising, promotional requests, and field communications **Post-Market Activities**: - Execute, manage, and close post-market activities, including complaints, recalls, and corrections - Prepare and submit all reporting activities associated with removals or corrections to US FDA and associated OUS Competent Authorities **General Support**: - Assess standards changes and the impact of new and revised regulatory requirements - Complete inquiries and requests from internal and external sources regarding regulatory processes and practices - Support supervisor with any other requests for information and documentation associated with regulatory laws and regulations **What You'll Bring** - Bachelor of Science, Engineering, or Medical Technology - Regulatory Affairs Certification (RAC) preferred - Minimum of 5 years of international experience in medical device Regulatory Affairs - Experience with Class I, II medical devices, MDDS, and CDS - Authorship and implementation of a minimum of 20 standard operating procedures - Experience managing post-market actions in the US - Familiarity with FDA electronic submission platforms (e.g., eSTAR, FURLS) - Experience with US/EU/Canada submissions - Deep understanding of global regulatory standards and frameworks, including IEC 62304, 21CFR820, ISO 13485, ISO 14971, IEC 62366, FDA guidances, European MDR, Health Canada Medica