Lead Quality & Regulatory Specialist

Femtech Insider Ltd.; City Of London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading health app company in London seeks a Lead Quality & Regulatory Specialist to develop and execute quality assurance strategies for Software as a Medical Device. Ideal candidates will have over 6 years of regulatory experience, strong knowledge of FDA and EU regulations, and a commitment to women's health. The role offers competitive pay, flexible working arrangements, and opportunities for professional growth.

Benefits

Competitive salary

Paid holiday and sick leave

Enhanced parental leave

5-week fully paid sabbatical

Qualifications

• 6+ years of experience in regulatory affairs, preferably in SaMD or medical devices.
• Proven track record of supporting FDA and EU regulatory submissions.
• In-depth knowledge of regulations including EU MDR, FDA requirements, ISO 13485.

Responsibilities

• Execute regulatory strategy with VP of Regulatory.
• Support technical documentation preparation for regulatory submissions.
• Maintain compliance with ISO 13485 and EU MDR.

Skills

Regulatory affairs expertise

Attention to detail

Project coordination

Strong communication skills

Education

Relevant degree in regulatory, scientific, engineering, legal, or medical field

Tools

MasterControl

Greenlight Guru

Job 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.