Quality and Regulatory Officer

# **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 record…