Lead Quality & Regulatory Specialist at Flo Health

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

25 Jan, 26

Salary

0.0

Posted On

27 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Assurance, Documentation Skills, Project Coordination, Cross-Functional Collaboration, Risk Classification, ISO 13485, FDA Submissions, EU MDR, Medical Devices, Digital Health, Audit Readiness, CAPA Management, Clinical Evaluation, Usability Testing, Digital Innovation

Industry

technology;Information and Internet

Description

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 We are looking for a highly skilled and motivated Lead Quality & Regulatory Specialist to support our VP of Regulatory in developing and executing quality assurance and regulatory affairs strategies for Software as a Medical Device (SaMD). This role will play a key part in preparing Flo’s features for regulatory clearance and certification in the US, UK and EU. You will be hands-on across projects, contributing to regulatory planning, documentation, quality system implementation, audit readiness, and cross-functional coordination. You will work closely with the Science, Product, Engineering, Legal, and Medical teams to ensure regulatory requirements are met while enabling innovation and speed. This is an exciting opportunity to help shape Flo’s regulatory function from the ground up. What You’ll Be Doing Regulatory Support & Execution Collaborate with the VP of Regulatory to execute regulatory strategy and ensure alignment 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 required 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 the development and implementation of Flo’s QMS in compliance with ISO 13485, 21 CFR Part 820, and EU MDR. Draft and maintain standard operating procedures (SOPs), work instructions, and templates. Contribute to the preparation of technical documentation for medical device files. Audit & Inspection Readiness Support internal and external audit readiness, including conducting mock audits and training stakeholders. Assist in managing corrective and preventive actions (CAPAs) and audit findings resolution. 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. Help drive a regulatory culture within the company by supporting internal education and training initiatives. What You Bring 6+ years of experience in regulatory affairs, with strong exposure to SaMD, medical devices, or digital health. Proven track record of supporting successful FDA and/or EU regulatory submissions (Class II or higher). In-depth knowledge of applicable regulations and standards, including EU MDR, FDA requirements, ISO 13485, ISO 14971 and IEC 62304. Strong documentation skills and attention to detail. Experience working in fast-paced, cross-functional environments. Excellent communication and project coordination abilities. A relevant degree in a regulatory, scientific, engineering, legal, or medical field. Nice to Have Experience with quality management system implementation from scratch. Familiarity with regulatory tools (e.g., MasterControl, Greenlight Guru). Prior experience supporting internal or external audits. Passion for women’s health and digital innovation Previous experience as a Person Responsible for Regulatory Compliance 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.

Responsibilities

The Lead Quality & Regulatory Specialist will support the VP of Regulatory in developing and executing quality assurance and regulatory 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 while ensuring compliance with regulatory requirements.