About Flo Health
Flo is the world’s #1 health app on a mission to build a better future for female health. Backed by a $200M investment led by General Atlantic, it became the first product of its kind to reach a $1B valuation in 2024. With 400M+ downloads and 75M+ monthly users, the app has 6M paid subscribers and the highest-rated experience in the App Store’s health category.
The Job
This senior role is responsible for providing strategic regulatory advice to the CLO and Chief Medical Officer, executives, and Board of Directors. The VP of Regulatory will create and implement regulatory strategies and guide the company's journey to certify certain features as medical devices, especially in the digital contraception and conception product segments.
Must Have Experience
- Over 10 years of regulatory affairs experience in the medical device domain focused on FDA and EU MDR.
- Relevant medical, legal, regulatory or similar education.
- Experience successfully bringing consumer SaMD to the US and EU markets (class IIa and higher).
- Excellent knowledge of relevant medical device regulations and regulatory practices in the EU and US.
- Knowledge of FDA operations and experience with advocacy with regulatory bodies.
- Experience building quality management systems compliant with ISO 13485.
- Knowledge of tooling to ensure ISO 13485 compliance.
- Understanding of digital health sector and approaches for SaMD certification.
- Cross-functional project management experience.
- Managerial experience.
Key Responsibilities
Digital Contraception Project:
- Identify and evaluate digital contraception algorithms including those developed by Flo.
- Assess clinical validity, regulatory status, usability, and clearance potential.
- Collaborate with Product and Engineering to refine and develop clearance-eligible digital contraceptive SaMD for US/EU.
- Support scientific validation and studies.
- Hire and lead a team of two QARA associates.
Regulatory Strategy Development and Implementation:
- Lead specification of intended use, device description, and risk classification for SaMD.
- Hire and manage team to meet roadmap milestones.
- Lead submission and pre-submission to FDA and other regulators for SaMD including contraceptive devices.
- Design training programs on SaMD regulatory topics and Flo’s QMS and technical documentation.
Project Management for QMS and Technical File Development:
- Identify gaps relative to EU MDR, 21 CFR Part 820, ISO 13485, and other relevant standards.
- Document and develop required processes and procedures.
- Oversee creation and review of regulatory documents.
- Support submissions and compliance for technical files and QMS.
Audit and Inspection Readiness:
- Prepare organization for audits with training and mock audits for certification.
- Conduct internal audits, address findings, and represent company in external audits with regulators.
How We Work
Flo is a mission-led, product-driven team that values speed, focus, ownership, and craftsmanship. The culture encourages debate, shared decision-making, commitment, resilience, and dedication to better health outcomes.
What You'll Get
- Competitive salary and annual reviews.
- Opportunity to participate in performance incentive schemes.
- Paid holiday, sick leave, and female health leave.
- Enhanced parental leave and pay.
- Opportunities for professional growth and learning support.
- Flexible office and home working, including up to 2 months working abroad.
- Five-week paid sabbatical at 5-year anniversary.
- Flo Premium for friends & family, with additional health, pension, and wellbeing perks.
Diversity, Equity, and Inclusion
Flo is an equal opportunity employer that values diversity and inclusion and hires based on merit and skill. Applicants from all backgrounds, communities, and identities are welcomed. Privacy notice for applicants is provided.