Clinical Program Manager

Support FDA and Health Canada submissions by compiling, organizing and quality-checking the clinical documentation and study data that feed them, working alongside our regulatory consultants

Maintain clinical documentation in an inspection-ready state, consistent with our quality system and applicable standards

Ensure clinical activities and records align with design control and regulatory requirements

A strong foundation in clinical trial operations across multiple studies or programs, including study start-up, feasibility, site selection, activation, IRB submissions, clinical documentation and reporting

A background in medical devices, or other regulated healthcare environment, with an understanding of the regulatory and quality requirements that shape clinical studies

Proven stakeholder management capabilities, from internal technical teams through external investigators, KOLs, clinical sites and strategic partners

Experience preparing program status materials and supporting leadership updates

A hands-on approach, moving confidently between detailed execution and broader program oversight

History of contributing clinical sections to regulatory submissions (510(k), De Novo, IDE or equivalent)

Experience with milestone reporting for large grants and multi-stakeholder programs

Sound judgement around priorities, dependencies and risk, with the confidence to surface issues before they become problems

Adaptable and proactive, with a genuine enthusiasm for the dynamic, hands-on environment of a growing startup

What’s In It For You: You're joining at a crucial moment in the company’s history: before scale, when the decisions you make stick and have lasting impact on the product, the team, and the company we become.

Frontier Technology: Work on a platform with no direct commercial equivalent, alongside the researchers who invented it

Flexibility: High trust, real autonomy, and the flexibility to do your best work

Equity: Meaningful stock options in an early-stage company with institutional backing

Agency & Impact: Your decisions and innovations will shape the product, not just inform it

We Encourage Diverse Perspectives We believe that varied backgrounds, experiences, and perspectives help us solve complex problems, and recognize that expertise and potential are not always captured by a job description, so if you can help drive our mission forward, we encourage you to apply!

Please note that we are not able to provide immigration sponsorship at this time.