Regulatory Affairs Manager

Job TitleRegulatory Affairs Professionals (Medical Devices)Location Seoul, South KoreaAbout our Client A globally leading medical device manufacturing companyRole SummaryThe Regulatory Affairs Professional will be responsible for ensuring compliance throughout the lifecycle of medical devices, including those featuring AI technology. This position will develop regulatory strategies, manage global submissions, and work closely with cross-functional and international teams to secure market access. A major focus will be on catheter-related registrations and next-generation systems incorporating artificial intelligence.Key ResponsibilitiesManage or support regulatory submissions for Class III to higher medical devices to across global markets (e.g., USA, EU).Formulate regulatory strategies for AI-enabled features and ensure adherence to emerging global regulations for Software/AI as a Medical Device.Partner with R&D, Quality, and Clinical teams to embed regulatory requirements throughout product development.Prepare and compile comprehensive regulatory submissions (e.g., Technical Documentation, 510(k)).Track and interpret global regulatory changes and communicate updates internally.Act as a liaison with international regulatory authorities or regional RA teams to resolve inquiries or deficiencies.Assist with audits and inspections (ISO 13485, MDSAP, FDA, KGMP).Participate in risk assessments and design documentation reviews to maintain compliance.Provide regulatory input for product lifecycle planning and change management processes.Qualifications & Experience: Experience: 5–10 years in Regulatory Affairs within the medical device industry.Education: Bachelor’s degree or higher in Biomedical Engineering, Electrical/Electronic Engineering, or related discipline.Language: Advanced English proficiency (written and verbal).In-depth knowledge of global medical device regulations and standards (MDR, FDA 21 CFR, IEC 60601, ISO 13485, ISO 14971, ISO 10993).Proven experience preparing submission packages and managing communications with regulatory bodies.Familiarity with registration processes in EU, US, and other global markets.Ability to manage multiple projects and meet deadlines.Strong attention to detail, analytical, and organizational skills.Preferred: Experience with regulatory documentation for AI/ML-based features and invasive Class III devices (e.g., catheters).Preferred: Background in supporting external audits and inspections.Advantages of the role: Opportunity to work on advanced products, including AI-based medical software and high-risk devices.Direct collaboration with global teams, including HQ and manufacturing sites.Exposure to complex and evolving regulatory frameworks (FDA, EU MDR) for professional growth.Strategic role combining technical expertise with influence on global regulatory strategy.Inclusive and collaborative team culture that values diversity and continuous learning.ContactMay Lwin, Permanent Associate Consultant02 6200 9787May.Lwin@adecco.com