Lead Quality & Regulatory Specialist
Posted on November 10, 2025 (about 1 hour ago)
About Flo
Flo is the world's #1 health & fitness app worldwide on a mission to build a better future for female health. Backed by a $200M investment led by General Atlantic, we became the first product of our kind to reach a $1B valuation in 2024. With 6M paid subscribers and the highest-rated experience in the App Store’s health category, Flo has spent 10 years earning trust at scale. The company is now building the next generation of digital health that is AI-powered, privacy-first, and clinically backed to help users understand their bodies better.
The Job
We are seeking a highly skilled and motivated Lead Quality & Regulatory Specialist to support the VP of Regulatory in developing and executing quality assurance and regulatory affairs strategies for Software as a Medical Device (SaMD). This role involves preparing Flo’s features for regulatory clearance and certification in the US, UK, and EU. The role is hands-on across projects, involving regulatory planning, documentation, quality system implementation, audit readiness, and cross-functional coordination.
Responsibilities
Regulatory Support & Execution:
- Collaborate with the VP of Regulatory to execute regulatory strategy aligned with business objectives.
- Support the development of intended use statements, qualification & risk classification, and device descriptions for Flo’s SaMD products.
- Prepare and review regulatory documentation for submissions to FDA (510(k), De Novo) and Notified Bodies (EU MDR).
- Assist in planning and executing pre-submissions, regulatory interactions, and responses to authority feedback.
Quality Assurance & Compliance:
- Support development and implementation of Flo’s QMS in compliance with ISO 13485, 21 CFR Part 820, and EU MDR.
- Draft and maintain SOPs, work instructions, and templates.
- Contribute to preparation of technical documentation for medical device files.
Audit & Inspection Readiness:
- Support internal and external audit readiness including mock audits, training stakeholders, managing CAPAs, and resolving audit findings.
Cross-Functional Collaboration:
- Work with Product, Engineering, Medical, and Science teams to align product development with regulatory requirements.
- Collaborate on clinical evaluation, usability testing, and validation plans for digital contraceptive features.
- Support internal education and training to drive a regulatory culture within the company.
Qualifications
- 6+ years in regulatory affairs with strong exposure to SaMD, medical devices, or digital health.
- Proven successful FDA and/or EU regulatory submission experience (Class II or higher).
- In-depth knowledge of EU MDR, FDA regulations, ISO 13485, ISO 14971, and IEC 62304.
- Strong documentation skills and attention to detail.
- Experience in fast-paced, cross-functional environments.
- Excellent communication and project coordination skills.
- Relevant degree in regulatory, scientific, engineering, legal, or medical field.
Nice to Have
- Experience with quality management system implementation from scratch.
- Familiarity with regulatory tools like MasterControl or Greenlight Guru.
- Prior audit support experience.
- Passion for women’s health and digital innovation.
- Experience as a Person Responsible for Regulatory Compliance.
Culture and Benefits
Flo is a mission-led, product-driven team that moves fast, stays focused, and takes ownership. The company supports impact with competitive salary, annual reviews, performance incentives, paid holidays, sick and female health leave, enhanced parental leave, professional growth opportunities, flexible office & home working, sabbaticals, and health and wellbeing perks. Flo is an equal opportunity employer committed to diversity, equity, and inclusion.
How to Apply
Please visit the Flo Health job board page to apply for this position: https://job-boards.greenhouse.io/flohealth/jobs/7509010003?gh_jid=7509010003