Senior Regulatory Affairs Program Manager (Koren speaking)
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Job Summary
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 womens medical path.
Sonios mission is to improve womens and childrens health by promoting access and quality of care through technological innovation medical expertise and collective intelligence.
About the role
Youll join a newly created team that will work on synergy projects between Sonio and Samsung. Youll 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
Youll 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 youll 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:
Bachelors 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 (ISOCFR 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
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
