USAHead of Regulatory
2 нед. назад
USAHeadHybrid
fda 510(k)regulatory filingshealth canada medical device licenseeu mdruk mhra registrationaustralian tga
Lead and execute global regulatory strategy for a growing healthtech AI company focused on dental care.
Обязанности
- is looking for a Head of Regulatory to own the critical regulatory function at a growing Healthtech AI company. As a key member of the Engineering team, reporting to our VP of Machine Learning & Compliance. This is an incredible opportunity to help lead the future of dental care — by building and leading the regulatory function as we scale.
- Develop, lead, and execute ’s global regulatory strategy, ensuring alignment with business goals and evolving international requirements.
- Own the planning, coordination, and submission of regulatory filings, including FDA 510(k), De Novo, Health Canada Medical Device License (MDL), EU MDR (via SGS NB and Casus EU RP), UK MHRA registration (via Casus UK RP), and Australian TGA (via sponsor Emergo by UL).
- Serve as the primary point of contact with regulatory authorities (e.g., FDA, Health Canada, MHRA, TGA, EU Notified Bodies) for product approvals, QMS compliance, and ongoing reporting.
- Interpret and communicate new or evolving global regulatory requirements across internal stakeholders, and incorporate them into ’s regulatory and quality systems.
- Partner with Product, Clinical, Engineering, and QA teams to ensure regulatory requirements are embedded throughout the product lifecycle—including design controls, validation, verification, and risk management.
- Manage development and maintenance of submission-ready documentation and regulatory dossiers.
- Provide regulatory input for clinical studies, real-world evidence programs, and data usage strategies.
- Collaborate with the VP of Machine Learning & Compliance and Director of Security to align regulatory strategies with privacy, cybersecurity, and AI risk management frameworks.
- Support regulatory due diligence for partnerships, audits, and customer-facing compliance engagements.
- Lead inspections and audits from regulatory authorities and Notified Bodies, and ensure timely resolution of findings.
- Build and manage the regulatory team as scales globally.
Требования
- 7+ years of experience in regulatory affairs for medical devices, including 2+ years with software as a medical device (SaMD) under FDA and at least one international regulatory framework (e.g., Health Canada, EU MDR, MHRA, TGA).
- Proven success managing regulatory submissions and approvals in multiple jurisdictions (e.g., FDA 510(k), De Novo, CE Marking, MDEL, UK MHRA registration, TGA conformity assessments).
- Deep knowledge of global regulatory frameworks including: U.S. FDA (21 CFR Part 820, SaMD guidance)
- Canada’s Medical Devices Regulations
- EU MDR and IVDR (including Notified Body processes)
- UK Medical Device Regulations
- Australian TGA (including sponsor model)
- Experience interacting directly with agencies and notified bodies, including leading meetings and responses to questions or deficiencies.
- Expertise in ISO 13485, ISO 14971, and IEC 62304; familiarity with ISO 27001 and data protection standards (HIPAA, GDPR) a plus.
- Strong knowledge of quality management systems and compliance audits, including internal and external inspection readiness.
- Excellent communication skills, including the ability to translate technical and regulatory language for cross-functional teams.
- High degree of ownership, self-direction, and comfort working in fast-paced, high-growth environments.
- Bachelor's degree in a scientific or engineering discipline required; advanced degree (e.g., MS, PhD, JD, MPH) or RAC credential preferred.
Другое
- is the world-leader in dental AI. Already, thousands of dental providers and insurers rely on our platform to deliver the best possible care. Now, we’re looking for talented people to fulfill our mission: improve oral health for all.
- is where builders become leaders. Everyone here loves to make new things: new products, new partnerships, new content, and a new category of AI technology. And as grows ridiculously fast, so will you.
- Simply put, there’s no better place to accelerate your career. Come join us!
- Competitive Compensation and Equity
- Hybrid workplace that provides flexibility, vibrant in-person workspaces, and the ability to build strong connections across all of - regardless of location
- 401k plans with a matching program
- Medical, Dental and Vision coverage: 99% employee premium covered, 75% dependent premium covered
- Life and AD+D Insurance
- 8 weeks Paid Parental Leave
- Optional HSA with Employer contribution
- Flexible Time Off and company paid holidays
- Annual Learning and Development Stipend
- We have a unique hybrid workplace at — which combines the teamwork of meeting in person, with the flexibility of working from anywhere.
- Many of our positions are based in San Mateo, New York City, Boston, and Salt Lake City. The Jetters who live in these “geo-hubs” come to the office on Tuesdays and Wednesdays, while having the option to work from home the rest of the week.
- Our People Team is happy to answer any questions about what hybrid work means for your specific role!
- Excellence: Aim Higher
- Velocity: Quickly Deliver Results
- Ownership: Go the Extra Mile
- Win-win: Care Deeply
- Included on Best Places to Work by BuiltIn lists in 2026 : #3 overall in the US, #1 in NYC, #1 in San Francisco, and #2 in Boston
- #4 on FastCompanys's Most Innovative Companies list in Healthcare for 2026
- Named one of the TIME Best Inventions of 2024
- Recognized in Newsweek ’s Most Loved Workplaces in America 2024
- Won the Dental Health category at the Digital Health Awards 2024 and 2024 Best Places to Work by Built In
- Recognized as one of the Top Startups of 2023 by LinkedIn
- Included on the definitive 2022 Forbes AI 50
- is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We believe diversity enriches our team so we hire people with a wide range of identities, backgrounds, and experiences. Even if you don't meet 100% of the qualifications for this job, we strongly encourage you to apply!
- If you are a Colorado resident: Please contact us by emailing recruiting@.ai to receive compensation and benefits information for this role. Please include the job title in the subject line of the email.