Flo is the world #1 health & fitness app worldwide focused on female health, backed by a $200M investment, reaching a $1B valuation in 2024 with 6M paid subscribers.

This role supports the VP of Regulatory in quality assurance and regulatory affairs for Software as a Medical Device (SaMD), preparing features for regulatory clearance and certification in the US, UK, and EU.

Responsibilities include regulatory strategy execution, development of intended use statements, regulatory documentation for FDA and EU MDR, quality management system implementation, audit readiness, and cross-functional collaboration with product, engineering, medical, and science teams.

Requirements include 6+ years in regulatory affairs, experience with FDA/EU submissions, knowledge of regulations like EU MDR, ISO 13485, ISO 14971, IEC 62304, strong documentation skills, and excellent communication.

Preferred qualifications include quality management system implementation, familiarity with regulatory tools, audit support experience, passion for women's health, and prior compliance responsibility.

Flo offers a competitive salary, performance incentives, paid leave, professional growth opportunities, flexible work options, sabbaticals, and wellbeing perks.

Diversity and inclusion are core values, welcoming applicants from all backgrounds.