layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Head of Regulatory at Overjet | LAYIQ

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.
Why Overjet?
Competitive Compensation and Equity
Hybrid workplace that provides flexibility, vibrant in-person workspaces, and the ability to build strong connections across all of Overjet - 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
Our Hybrid Workplace
We have a unique hybrid workplace at Overjet — 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!
Overjet's Values
Excellence: Aim Higher
Velocity: Quickly Deliver Results
Ownership: Go the Extra Mile
Win-win: Care Deeply
Company Recognition
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
EEOC
Overjet 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@overjet.ai to receive compensation and benefits information for this role. Please include the job title in the subject line of the email.

Head of Regulatory

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