Head of Regulatory Affairs

Our Mission Perifit is a profitable and fast-growing femtech startup based in Paris France. Turnover was multiplied by 100 in 5 years Our goal is to assist women worldwide with the most challenging moments in their lives - moments that are heavily under-addressed - and do benefit from fun and effective self-care solutions. Our first product the Perifit (a connected probe and its mobile games) launched in 2018 has become the #1 connected solution for pelvic floor rehabilitation. As of now it has helped a whooping 500.000 women cure themselves and is the best-ranked app in its category. We now develop innovative pelvic floor trainers and breast pumps that use the most recent technologies to help women improve their lives. Our mission is to empower women to take control of their health and improve their overall well-being. Our team grew from 2 co-founders to approximately 40 employees in three years (2020 to 2025) and we operate in a truly global environment with customers and partners around the world. At Perifit we stand for equality inclusivity benevolence and wellbeing for both our clients and our employees. Joining Perifit means being part of a dynamic mission‑driven team that is making a real difference in womens lives and having the opportunity to contribute to a growing and innovative startup in the Femtech industry We're very proud of our values FREEDOM FEMINISM STARTUP MINDSET REAL IMPACT NO EGO Why we need you We have grown fast iterating quickly on our products to deliver what our customers need and have become one of the top femtech companies in the world. As we expand our product portfolio enter new markets and continuously improve our solutions we need to strengthen our Quality and Regulatory processes. We need to ensure compliance of the product while remaining easy to manufacture high-quality and customer-friendly. We are looking for a solid and pragmatic leader to manage multiple products across diverse markets efficiently. As our Head of QARA you will be the strategic and operational leader ensuring regulatory compliance product quality and smooth market access for our pelvic floor trainers and breast pumps in Europe (Class I) and the US (Class II under FDA 510(k)). Your mission will be to drive regulatory submissions ensure ISO 13485 compliance by implementing quality processes that balance efficiency and compliance. With your expertise we can continue delivering trusted high-quality solutions that positively impact womens health worldwide. What you will be doing You will lead regulatory and quality assurance efforts to ensure Perifits products comply with international standards while maintaining customer satisfaction. You will improve production quality and reduce customer returns through post-market surveillance and CAPA processes. Maintaining and refining our ISO 13485-certified QMS you will ensure regulatory and quality processes remain efficient and adaptable. You will develop and execute regulatory strategies for product launches ensuring FDA Class II CE marking (Class I) and ISO 13485 compliance. As the leader of the QARA team you will foster a compliance culture while avoid unnecessary bureaucracy. You will collaborate with R&D Manufacturing and Supply Chain teams to integrate compliance and quality into product development and production. Key Skills Proofreading Adobe Acrobat FDA Regulations Manufacturing & Controls Biotechnology Clinical Trials Research & Development GLP cGMP Product Development Chemistry Writing Skills Required Experience : Director Employment Type Employment Type : Full‑Time Experience Experience : years Vacancy Vacancy : 1 #J-18808-Ljbffr