Senior Regulatory Affairs Program Manager
il y a 13 heures
Senior Regulatory Affairs Program Manager (Koren speaking) Sonio is a mission-driven company focused on improving women’s and children’s health through AI‑driven prenatal screening tools. We are seeking a senior professional to lead regulatory affairs for our AI/ML‑enabled medical devices. About The RoleYou will join a newly created team working on synergy projects between Sonio and Samsung, combining hardware and software with cutting‑edge AI/ML. Your responsibilities include developing and executing robust regulatory strategies, preparing high‑quality submissions, and serving as the primary liaison with regulatory bodies such as the FDA to ensure global market entry and 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 pre‑market submission files (e.g., 510(k)). Serve as subject‑matter expert on FDA regulations and guidance pertinent to AI/ML and software‑based medical devices. Act as 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. Qualifications 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 and verbal communication and project‑management skills. Exceptional written and verbal communication skills in English and Korean, with native or near‑native fluency. Location & TravelYou’ll initially work 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 relocate to Seoul, Korea, full‑time, joining Samsung as an internal regulatory affairs expert for AI/ML medical devices. CompensationSalary: €80k + 10% bonus (Paris) / $160k + 10% bonus (Boston). Compensation range: €75 K‑85 K. We move fast and aspire to be transparent over the process – from the first chat to an offer should not exceed a month. We also aim to respond to every application within a week. If you have not heard from us, please follow up at careers@sonio.ai. #J-18808-Ljbffr
-
Regulatory Affairs Senior Manager
il y a 2 semaines
Paris, France Cellectis Temps pleinPrise de poste non définie BAC +5 Paris Nombre de postes non défini CDI Rémunération non définie **Description du poste et des missions**: **WHO WE ARE** Cellectis is a **global clinical-stage biopharmaceutical** company. **Pioneers and innovators** in our field, our mission is to develop **innovative treatments** for **patients with unmet medical...
-
Senior Manager Regulatory Affairs
il y a 13 heures
Paris, France elemed Temps plein🔎 Title: Senior Regulatory Affairs Consultant🔸 The CompanyIf you are a QA/RA professional with an interest in innovation and groundbreaking development, we have an incredible role for you. This is a chance to join an established midsize Software as a Medical Device company.🔹 As a Regulatory Affairs Consultant your mission is to:Develop and execute...
-
Senior Regulatory Affairs Lead — AI Medical Devices
il y a 12 heures
Paris, France Sonio Temps pleinA leading health tech company is seeking a Senior Regulatory Affairs Program Manager fluent in English and Korean. This role involves developing regulatory strategies for AI/ML-enabled medical devices and serving as the primary liaison with regulatory bodies like the FDA. The ideal candidate has over 6 years of experience in the medical device industry and...
-
Senior Regulatory Affairs Consultant MedTech FDA
il y a 14 heures
Paris, France elemed Temps pleinA leading MedTech recruitment firm is seeking a Senior Regulatory Affairs Consultant to develop and execute regulatory strategies that align with global requirements. The role requires 5-7 years of regulatory experience within medical devices, expertise in leading FDA submissions, and a solid grasp of project management. This position offers the opportunity...
-
Manager of Regulatory Affairs, Quality
il y a 2 semaines
Boulevard Bourdon, Paris, France TheraPanacea Temps pleinTheraPanacea is seeking a Manager of Regulatory Affairs, Quality & Compliance to lead global regulatory strategy, quality systems, and compliance across our medical technology portfolio. This role is responsible for securing and maintaining regulatory approvals (FDA, CE and other markets), building and maintaining a ISO–compliant Quality Management System,...
-
Regulatory Affairs Manager
il y a 1 semaine
Paris, France Perrigo Temps plein**Description générale**: **_ HRA Pharma Rare Diseases_** is dedicated to bringing the best care and services to people living with rare diseases and is committed to supporting healthcare professionals all over the world. We have over 15 years’ experience in rare and ultra-rare diseases with a portfolio of medicines that address Cushing’s syndrome and...
-
Regulatory Affairs Manager
il y a 6 jours
Paris, France Perrigo Temps plein**Description générale**: **_ HRA Pharma Rare Diseases_** is dedicated to bringing the best care and services to people living with rare diseases and is committed to supporting healthcare professionals all over the world. We have over 15 years’ experience in rare and ultra-rare diseases with a portfolio of medicines that address Cushing’s syndrome and...
-
Senior Manager/ Associate Director, Regulatory
il y a 1 jour
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...
-
Senior Manager, Spectrum
il y a 4 jours
Paris, France Shure Temps pleinOverview: **Shure **is looking for an **experienced professional** to ensure access to spectrum in Europe and support Shure’s strategy and growth vision. Reporting to the **Global Head of Spectrum & Regulatory Affairs**, the Senior Manager will be well versed in the world of **Spectrum, Cybersecurity and Artificial Intelligence regulations**, and will...
-
Regulatory Affairs Manager M/F
il y a 2 semaines
Paris, Île-de-France Ceva Sante Animale Temps pleinRegulatory Affairs Manager M/FThe success of a company depends on the passionate people we partner with.Together, let's share our talents.As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which...
