400M+ downloads. 75M+ monthly users. A decade of building – and we’re still accelerating.
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, we became the first product of our kind to reach a $1B valuation in 2024 – and we’re not slowing down.With 6M paid subscribers and the highest-rated experience in the App Store’s health category, we’ve spent 10 years earning trust at scale. Now, we’re building the next generation of digital health – AI-powered, privacy-first, clinically backed – to help our users know their body better.
The job
Flo’s enjoyed strong growth in the last few years having more than doubled in headcount and valuation. As we continue to expand our products and services towards IPO, we aim to diversify our product portfolio by including features that would fall under medical device regulations, such as contraception and conception products.It’s a senior role, responsible for providing strategic regulatory advice to the CLO and Chief Medical Officer, company’s executives, and Board of Directors. The role is expected to create and implement regulatory strategy for the company and guide the company in its journey to certify some of its features as medical devices.
Must have experience:
- Over 10 years of regulatory affairs experience in the medical device domain (with a focus on FDA and EU MDR);
- Medical, legal, regulatory or similar education relevant to the field;
- Experience of successfully bringing consumer SaMD to the market in the US and the EU (class IIa and higher);
- Excellent knowledge of relevant medical device regulations and applicable practice in the EU and US;
- Knowledge of FDA’s ways of working and experience with advocacy with regulatory bodies;
- Experience in building quality management systems compliant with ISO 13485;
- Knowledge of relevant tooling to ensure compliance with ISO 13485;
- Knowledge of the digital health segment and approaches to certification of SAMD;
- Cross-functional project management experience;
- Managerial experience.
What we expect you to do:
Work on the digital contraception project:
- Identify digital contraception algorithms currently available, including the ones developed by the Company
- Evaluate their clinical validity, regulatory status, usability, and potential for clearance with regulatory authorities
- Together with Product and Engineering, refine and develop a product that would be eligible for clearance as a digital contraceptive SaMD in the US/EU
- Support the Science and Medical team on required scientific validation and studies
- Hire and lead a team of two QARA associates
Regulatory Strategy Development and Implementation
- Lead on the specification of intended use, device description, and risk classification for proposed SaMD
- Hire and line manage team required to achieve milestones/deliverables as per the roadmap
- Lead on submission and pre-submission of the SAMD, including contraception device, to FDA and other relevant regulatory bodies.
- Design a comprehensive training program covering key SaMD regulatory topics in general, and Flo Health’s QMS and technical documentation
Project Management of Development and Submission of Quality Management System (QMS) and Technical File
- Identify gaps in existing processes and procedures at Flo Health, relative to the requirements of EU MDR, 21 CFR Part 820, ISO 13485, and other applicable regulations and standards
- Document existing processes, and develop and document additional required processes and procedures.
- Provide oversight of the creation and review of regulatory documents
- Support for technical file submissions and QMS compliance
Audit and Inspection Readiness
- Prepare organisation for internal and external audits, with training and mock audits, required for certification.
- Arrange the conduct of internal audits and lead on the addressing of findings.
- Represent the organisation on medical device regulatory issues in external audits, with regulators, and lead on addressing findings
How we work
We’re a mission-led, product-driven team. We move fast, stay focused and take ownership – from brief to build to impact. Debate is encouraged. Decisions are shared. We care about craft, ship with purpose, and always raise the bar.You’ll be working with people who take their work seriously, not themselves. It takes commitment, resilience, and the drive to keep going when things get tough. Because better health outcomes are worth it.
What you'll get
We support impact with meaningful reward. Here’s what that looks like:
- Competitive salary and annual reviews
- Opportunity to participate in Flo’s performance incentive scheme
- Paid holiday, sick leave, and female health leave
- Enhanced parental leave and pay for maternity, paternity, same-sex and adoptive parents
- Accelerated professional growth through world-changing work and learning support
- Flexible office + home working, up to 2 months a year working abroad
- 5-week fully paid sabbatical at 5-year Floversary
- Flo Premium for friends & family, plus more health, pension and wellbeing perks
Diversity, equity and inclusion
Our strength is in our differences. At Flo, hiring is based on merit, skill and what you bring to the role – nothing else. We’re proud to be an equal opportunity employer, and we welcome applicants from all backgrounds, communities and identities. Read our privacy notice for job applicants.
