Quality & Regulatory Officer

📆 40 Hours per week(Happy to discuss some part time options, we see the need for this role as being a minimum 32 hours a week)
🌍 UK, Remote
💰 £35,000 - £40,000(We're transparent about our salary range - our offers start at the lower end, with room to grow based on performance.)

Why Hertility?

Hertility was born out of a need for preventative, personalised and dedicated expert healthcare across a woman’s hormonal lifespan. Hertility’s at-home diagnostic testing, telemedicine, treatments, prescriptions, and clinical services provide advanced insights into reproductive health, fertility decline, and the onset of menopause, as well as the diagnosis of 18 conditions. Hertility reduces diagnosis times for some conditions from nine years to six days. 🚀

Having done over 29 clinical studies and published in leading scientific journals and presented at over 25 National and International scientific and clinical conferences, Hertility is committed to expanding its research and clinical programmes, deepening our understanding of reproductive health and influencing policy.

By setting a new standard of scientific rigour and education in women’s health, we’re nurturing the Mother of all Movements. One powered by a new generation of women backing themselves, their bodies and their life choices, from menstruation through menopause. ❤️

Why You’ll Love This Role

As a Quality & Regulatory Officer you’ll play an integral role in our growing company. We’re seeking a talented and versatile Quality & Regulatory Officer to join our Quality Team, you’ll be at the centre of how Hertility maintains safe, compliant and world class products from our HER-KIT to our emerging Software as a Medical Device (SaMD).

In this role, you’ll support audits, documentation, risk management, supplier oversight and post market activities - working across R&D, Clinical, Operations, Data, Product and more. You’ll be trained, supported and trusted with meaningful responsibility, and we’re excited to see you flourish in this role. If you’re passionate about making a difference in women’s health, this role is for you!🌸

What You’ll Be Doing 🌟

📄 Documentation & QMS

Assisting in the management of the lifecycle of controlled documents in Qualio (our QMS system), driving authors to meet review and approval deadlines.

Support standard operational procedures, work instructions, medical device technical documents and template drafting.

Assign training and track completion for document updates.

Help organise internal quality records, logs and dashboards.

🔍 Audits & Compliance

Support with internal and external audits against ISO 13485 and ISO/IEC 27001 standards.

Support Corrective and Preventative Actions (CAPAs), Non-Conformances (NC), change controls and follow up actions, including timely and structured root cause analysis (e.g. 5 whys, fishbone) and tracking effectiveness.

Drive audit readiness by maintaining organised evidence logs aligned to ISO 13485 and ISO 27001 requirements and contributing to ongoing quality assurance activities.

📊 Risk & Post-Market Surveillance

Coordinate the collection of Post-Market Surveillance (PMS) inputs.

Support risk register updates and Design History Files.

Contribute to Management Review quality reporting.

🤝 Supplier & Operational Quality

Support with Supplier Onboarding, Supplier Evaluation Reports and ongoing supplier monitoring.

Conduct quality checks on our medical device components and logistics providers, escalating non conformances independently.

🧬 SaMD Exposure (Training Provided)

Support design control documentation for regulated software

Help track verification & validation activities

All employees are required to work in alignment with Hertility’s Quality Management System and ensure their activities support compliance with ISO 13485 (Medical Devices) and ISO 27001 (ISMS), including following controlled processes, maintaining accurate records, and participating in required training.

What We’re Looking For 🎯

You’ll thrive if you’re passionate about fertility and reproductive health and bring:

💡 Knowledge & Skills — you’ll thrive if you bring:

A minimum of 3 years experience in a Quality/Regulated setting.

Experience with ISO 13485 (Medical Device), ISO 27001 (ISMS) or regulated environments

Exposure to International Medical Device Regulatory Frameworks (e.g. FDA, TGA, MOHAP)

Strong attention to detail and structured approach to organisation and process management.

Excellent written communication and documentation skills.

A proactive, curious mindset with the ability to manage tasks independently and follow through to completion.

Comfortable working remotely with high levels of autonomy and accountability.

Willingness to travel, occasionally to London for audits, team sessions or key activities.

🔑 Nice to haves (not required, training provided):

Degree in a scientific, engineering or healthcare-related field (preferred, not essential)

Experience with QMS platforms (Qualio, MasterControl, QPulse etc.)

Exposure to auditing, CAPA/NCR management or PMS activities

Interest in Software as a Medical Device (SaMD) development

🫶 Team Player

Act with integrity and make decisions aligned with regulatory, ethical and patient safety requirements.

Confidently raise risks and challenges where quality or compliance may be compromised.

Confident working cross functionally, adapting communication to different teams, and escalating risks, non conformances or uncertainties in a timely manner.

Comfortable working in a fast moving environment with evolving systems, strong analytical thinking to support risk based decision making.

Your Team 💪🏼

You will be working and reporting directly to ourDr Bethan Harper, Quality & Regulatory Manager. You’ll collaborate with Clinical, Operations, Product, Engineering, Data, Customer Experience, Research and our Founders as part of our wider mission.

Our Culture & Values 🌈
At Hertility, we’re all about ovary-acting with purpose! We believe in a world where every womb has access to the healthcare it needs. We’re bold, focused, dependable and proud - lifting each other up, working with heart and staying true to our mission.💪

Flexibility in this Role

Ideally, we would have someone in this role working full time, which for us is 40 hours per week. It’s a busy, fast, moving and complex role. However, we understand how important flexibility is and therefore feel that the role could be completed in anything between 32 and 40 hours per week. We’re flexible in terms of what this looks like, our operating hours are between 8am and 6pm from Monday to Friday so as long as your hours fit into this time slot we can make it work.

Ready to Apply? 📅

• Apply by:27 July 2026

• Interviews Begin:from 20 July 2026

Interview Process:

1. Initial Phone Interview
   A 15-minute conversation with a member of our Talent Team to get to know you better and answer any initial questions.
   

2. Competency Based Interview
   A structured interview with Dr Bethan Harper, our Quality & Regulatory Manager, and Amara Patel, Customer Experience Manager focusing on your experience and key competencies relevant to the role.

3. Final Interview
   A final stage interview will be two parts with a 15 minute conversation with two of our Co-Founders - Dr Natalie Getreu (COO) and Deirdre O’Neill CCO.
   

4. Start Date: Early September 2026

If you’re excited to be part of a team that’s redefining women’s health, apply now! We can’t wait to meet you. 🎉

Perks & Benefits 🎉

🌴 33 Days of Paid Leave: Includes public holidays,

🎄3 Days Discretionary Additional time off between Christmas and New Year.

🧬 We are Reproductively Responsible™

💻 Company Laptop: The tech you need to succeed!

🏠 Remote-First: Work from anywhere with the flexibility to do what matters most to you.

🕒 Flexible Working Hours: 40 hours per week, with the freedom to choose your start and finish times. We trust our team to manage their schedules and deliver great results.

🌱Wellbeing: Receive a £40 monthly wellbeing allowance to spend on anything that brings you joy.

💼 Pension Scheme: 5% employer contribution salary sacrifice pension with a 5% employee match.

💆 Mental Health Support: In house counselling available anytime.

🩺 Free Hertility Services: Complimentary hormone and fertility tests for you, plus discounts for friends and family.

👶 Enhanced Parental Leave & First-Time Parents Benefits: Support through all stages of family life.

🩸 Menstrual Leave: Time to rest and restore when your body’s rhythms change.

💰 Financial Advisor Access: Get guidance on financial planning.

🏖 Work from Anywhere: Embrace true flexibility with the option to work from anywhere in the world, one month per destination, up to 12 countries across 12 months.

🌍 We’re Here to Support You

At Hertility, we want every candidate to feel comfortable and confident throughout the hiring process 💛. If you need any adjustments, whether that’s interview timings, communication preferences, or accessibility support, just drop us a line. Let us know how we can help!😊

🤝 Diversity & Inclusion

Just like the diversity in every cell, Hertility thrives on a range of perspectives and experiences. We’re proud to be an equal opportunity employer and celebrate the unique contributions each team member brings to our work.