Regulatory Manager

About Us Hormona is a data-driven women’s health company on a mission to revolutionize female health. Our award-winning app is the first comprehensive, personalized hormone-tracking platform that helps women understand and optimize their hormonal well-being. With features like cycle tracking, symptom logging, personalized insights, and expert-backed recommendations, we’re leading the way in “Hormone Health.” The Role We’re looking for an experienced Regulatory Manager to join us on a maternity leave cover contract (12 months). This is a pivotal role ensuring compliance across our Software as a Medical Device (SaMD), In Vitro Diagnostic (IVD), and wellness products as we continue to scale globally. The successful candidate will also be formally appointed as Management Representative and Person Responsible for Regulatory Compliance (PRRC) under EU IVDR, representing Hormona in all quality, regulatory, and compliance matters. Responsibilities Serve as Hormona’s Management Representative and PRRC, ensuring compliance with EU MDR 2017/745, and/or EU IVDR 2017/746. Maintain and continuously improve Hormona’s ISO 13485-compliant QMS, including document control, internal audits, CAPA, management reviews, and quality records, and supplier management. Oversee regulatory compliance of Hormona’s SaMD, IVD, and wellness products, ensuring conformity with the aforementioned regulations as well as EU General Safety and Performance Requirements (GSPR), EU AI Act and ongoing GDPR/HIPAA alignment in collaboration with the DPO. Author, review, and maintain regulatory and technical documentation in compliance with ISO 13485, IEC 62304, and EU IVDR, ensuring clarity, accuracy, and audit readiness across the Device Description, Risk Management, Verification and Validation, and Performance Evaluation files (Annex II & III). Plan and coordinate regulatory submissions and communications with Notified Bodies, competent authorities, and the FDA, including ethics committee submissions for clinical and performance evaluation studies. Oversee performance evaluation activities, ensuring study documentation, compliance oversight, and liaison with research partners meet IVDR and ethical requirements. Ensure cross-functional alignment of regulatory activities across clinical, data, software, and product teams, applying relevant standards such as ISO 14971, IEC 62304, and ISO 13485. Conduct regulatory review of content before publication to ensure compliance with regulatory, ethical, and marketing requirements, for both wellness and medical device products. Monitor evolving global regulatory frameworks and standards, providing proactive guidance and updates to internal teams. Demonstrate a hands-on, proactive approach, supporting cross-functional projects as needed in a dynamic startup environment, and report directly to the COO while collaborating closely with product, medical, and data/technical leads. Who you are: You’re an experienced, adaptable, and detail-oriented regulatory and quality professional passionate about transforming women’s health through innovation. You’re comfortable leading QARA processes, managing studies and suppliers, and compliance across medical and wellness product lines. You thrive in an agile startup setting where flexibility, ownership, and collaboration drive progress. Qualifications Minimum 4 years’ experience in Regulatory Affairs and/or Quality Assurance for medical devices or IVDs. Proven experience with ISO 13485 QMS implementation, maintenance, and improvement. Solid understanding of EU IVDR, MDR, and FDA 21 CFR Part 820 (QSR) or Quality Management System Regulation (QMSR). Familiarity with EU GSPR for wellness/non-medical products. Working knowledge of EU GDPR, with experience collaborating with a Data Protection Officer or compliance team. Experience with Notified Bodies, FDA submissions, and CE marking processes. Experience preparing and supporting ethics submissions and performance evaluation activities for medical device or IVD studies. Familiarity with IEC 62304, ISO 14971, and related SaMD/IVD standards. Skilled in technical documentation, regulatory submissions, and document control. Experience managing approved suppliers, contractors, and consultants within a regulated environment. Excellent communication skills and ability to work autonomously in a distributed team. Desirable: Experience in female health or endocrinology-related medical devices. Prior appointment as PRRC or Management Representative. Experience with AI/ML-enabled medical device software and/or awareness of EU AI Act compliance. Not Your Typical 9–5 This isn’t a standard job. At Hormona, we’re looking for someone with a unicorn mentality —creative, adaptable, and energized by challenges. You’ll thrive in a fast-moving environment, wear many hats, and help us push boundaries as we shape the future of female health. What we offer you