Compliance Officer executing Canadian FINTRAC/RPAA registrations and AML controls for Mercuryo’s crypto on/off - ramp and fiat remittance platform. Coordinating regulatory filings, investigations, testing, and cross - functional compliance projects.
About the role
- Senior Regulatory Affairs Specialist guiding FDA and international compliance for Function Health’s AI health platform. Supporting medical device submissions, quality systems, claims review, and regulatory strategy.
Responsibilities
- Partner with product managers from the requirements stage to set the regulatory path for new features
- Review member-facing claims, user experience, and AI-generated outputs against general wellness, clinical decision support, and medical device boundaries
- Prepare regulatory launch reviews and supporting documentation for sign-off
- Author and coordinate sections of 510(k), De Novo, and Pre-Submission packages
- Support design control documentation, risk management, and verification and validation evidence planning
- Support regulatory strategy, determinations, and submissions for international markets, such as the EU and UK
- Help maintain quality management system elements supporting regulatory work, including document control, design history files, CAPA input, and audit readiness
- Conduct regulatory change assessments for software, model, and labeling updates to cleared products
- Maintain submission trackers, device determinations, change assessment logs, and agency correspondence
- Monitor FDA guidance and policy on digital health and AI-enabled devices, and translate it into clear direction for teams
- Build lightweight regulatory processes and templates for product and research teams
- Work across lab testing, imaging, and AI-enabled products
- Report to the Principal Regulatory Affairs Specialist / Director, Regulatory Affairs
Requirements
- 5+ years of regulatory affairs experience with medical devices, software as a medical device (SaMD), or diagnostics
- Bachelor's degree in engineering, life sciences, or a related technical field
- Hands-on experience with 510(k), De Novo, or Pre-Submission work, including preparing submission content
- Working knowledge of FDA device regulations and guidance, including general wellness, clinical decision support software, and AI-enabled device software, plus ISO 13485, ISO 14971, and IEC 62304
- Familiarity with international medical device regulations, such as EU MDR and UK MHRA requirements
- Working knowledge of quality management system requirements under ISO 13485 and 21 CFR Part 820 (QMSR)
- Experience reviewing labeling, marketing, and in-product claims
- Clear writing, and the ability to turn regulatory requirements into practical guidance for product, engineering, and clinical teams
- Comfortable using AI tools to speed up regulatory work, with the judgment to verify and correct their outputs
- A bias toward action, and comfort prioritizing across several concurrent projects in a fast-moving environment
- AI/ML-enabled device experience, including predetermined change control plans and performance evaluation
- Laboratory-developed tests, CLIA, or in vitro diagnostics
- Imaging devices
- Device cybersecurity and post-market obligations, including complaint handling and adverse event reporting
- IRB submissions and oversight of human subjects research
- MDSAP audit experience
- RAC certification and experience at a startup or consumer health company
Benefits
- Competitive Base Salary
- Stock options
- Comprehensive health, dental, and vision plans for you and your family
- Flexible work environment
- Team off-sites and wellness initiatives
- Competitive vacation policy
- A culture that emphasizes continuous learning and personal growth
- Flexible working hours
- Dynamic work environment where creativity and innovation are encouraged
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