Senior Regulatory Affairs Program Manager
il y a 11 heures
About Sonio Each year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities on healthcare professionals. They can also be a source of stress for future parents. Resulting from 5 years of collaboration between world‑renowned experts from Necker Hospital and Ecole Polytechnique, Sonio uses artificial intelligence to improve prenatal screening and diagnosis. Based on patented algorithms and a proprietary expert database, Sonio aims to become the reference tool to help practitioners improve screening, reduce diagnostic errors, and optimize pregnant women’s medical path. Sonio's mission is to improve women's and children's health by promoting access and quality of care through technological innovation, medical expertise, and collective intelligence. About the role You’ll join a newly created team that will work on synergy projects between Sonio and Samsung. You’ll work on advanced technological projects mixing both hardware and software with cutting‑edge AI/ML. You will be responsible for developing and executing robust regulatory strategies, preparing high‑quality submissions, and serving as the primary liaison with regulatory bodies like the FDA to ensure our innovative products meet all requirements for global market entry and sustained compliance. Key Responsibilities Develop and implement comprehensive regulatory strategies for AI/ML‑enabled medical devices to ensure timely and successful market access. Prepare, compile, and submit high‑quality premarket submission files (e.g., 510(k)). Serve as the subject matter expert on FDA regulations and guidance pertinent to AI/ML and software‑based medical devices. Act as a primary liaison with the FDA and other regulatory bodies, managing communications and leading negotiations. Monitor the regulatory environment for changes related to SaMD and cybersecurity and assess their impact. Localisation You’ll be initially working in Paris or Boston, reporting to the Director of RAQA at Sonio, with regular travel to Samsung HQ in Korea. After two years, you’ll move to Seoul, Korea, full‑time, joining the Samsung organisation as an internal expert on Regulatory affairs for AI/ML medical devices. About the profile Sonio is a mission‑driven company, so interest in our mission is critical. Other requirements are: Bachelor's degree in a scientific, engineering, or related discipline. 6+ years of regulatory affairs experience within the medical device industry. Demonstrated experience preparing and managing FDA submissions for software‑based medical devices. In‑depth knowledge of FDA guidance, risk management (ISO 14971), and quality management systems (ISO 13485, 21 CFR 820). Strong understanding of the Total Product Life Cycle (TPLC) for medical devices. Excellent written/verbal communication and project management skills. Exceptional written and verbal communication skills in English and Korean, with native or near‑native fluency. Salary: €80k + 10% bonus for Paris / $160k + 10% for Boston We move fast and aspire to be transparent over the process – our objective is that the process from the first chat to an offer is no longer than a month. We also aspire to give an answer to every application in a week – if you have not heard from us, please follow up at careers@sonio.ai. #J-18808-Ljbffr
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Senior Regulatory Affairs Program Manager
il y a 1 jour
Paris, Île-de-France Sonio Temps pleinAbout SonioEach year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities on healthcare professionals. They can also be a source of stress for future parents.Resulting...
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Senior Regulatory Affairs Program Manager
il y a 21 heures
Paris, Île-de-France Sonio Temps pleinAbout SonioEach year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities on healthcare professionals. They can also be a source of stress for future parents.Resulting...
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Regulatory Affairs Manager
il y a 12 heures
Paris, France elemed Temps pleinOverviewTitle: Senior Consultant – Device Regulatory Documentation & ComplianceLocation: Paris (3 days onsite - 2 WFH)The CompanyWe believe great work happens when brilliant minds come together with a shared purpose. This biopharma company is known for its dedication to employee happiness, its collaborative environment, and its passion for bringing...
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Senior Manager/ Associate Director, Regulatory
il y a 2 semaines
Paris, France Stirling Q&R Ltd Temps pleinOn-site presence in the South of France once per month for 2-3 days. Stirling Q&R, a leading recruitment company, is currently assisting our esteemed client in the search for a highly experienced Senior Manager/Associate Director, Regulatory Affairs. Our client, a renowned global biotech company specializing in oncology, is dedicated to improving treatment...
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Regulatory Affairs Project Manager
il y a 2 semaines
Paris, France TFS HealthScience Temps pleinTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a** **Regulatory Affairs Project...
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Senior Manager CMC Regulatory
il y a 13 heures
Paris, France Ipsen Group Temps pleinCookie Notice**Title:**Senior Manager CMC Regulatory**Company:**Ipsen Innovation (SAS)**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France...
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il y a 2 semaines
Paris, France Nanobiotix Temps pleinNanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...
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Regulatory Affairs CMC Officer – Paris, France
il y a 10 heures
Paris, France Astek Middle East Temps pleinOverviewRegulatory Affairs CMC Officer – Paris, France (F/M) role at Alsinova, the CRO subsidiary of the Astek Group. Alsinova is currently recruiting a Regulatory Affairs CMC Officer to strengthen its regulatory affairs team and support strategic projects in the pharmaceutical industry.Your MissionWorking closely with our clients in the Life Sciences...
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Senior/ Regulatory Affairs Manager
il y a 2 semaines
Paris, France Novasyte Temps pleinJob Overview Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision. Essential Functions - Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project,...
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Regulatory Affairs Officer 610
il y a 1 semaine
Paris, France ProductLife Group Temps pleinIn the context of a new project, we are looking for a Regulatory Affairs Officer in medical devises to join our teams in Paris. **Responsibilities**: Write the dossiers and coordinate with the different contributors (R&D, Production, QA, Clinical,..) Ensure that the constitution of the registration dossiers is in accordance with the new European regulation...
