As a Regulatory Affairs Professional, you will play a key role in ensuring regulatory compliance throughout the product lifecycle of ultrasound systems, catheters, and transducers — including those with AI-powered features. He or she will collaborate with cross-functional teams and international regulatory stakeholders to support global product registrations and enable market access. This role is especially critical in driving regulatory strategy and execution for catheter-related registrations and next-generation systems incorporating artificial intelligence. siemens-healthineers Regulatory Affairs Professional (대리 – 차장)

- Lead or support regulatory submissions for ultrasound systems, transducers, and catheters in global markets (e.g., USA, EU, etc.). - Develop regulatory strategies for AI-enabled features and ensure compliance with emerging global regulations on Software/AI as a Medical Device. - Collaborate with R&D, Quality, and Clinical teams to integrate regulatory requirements throughout the product development lifecycle. - Prepare and compile high-quality regulatory submissions (e.g., Technical Documentation, 510(k), etc.). - Monitor and interpret evolving global regulatory requirements and communicate updates to internal teams. - Serve as liaison with international regulatory authorities or regional RA counterparts to address inquiries or deficiencies. - Support regulatory aspects of audits and inspections (e.g., ISO 13485, MDSAP, FDA, KGMP, etc.). - Contribute to risk assessments and design documentation reviews to ensure regulatory compliance. - Provide regulatory input to product lifecycle planning and change management processes.

Advanced Level of English Regulatory affairs experience for FDA 510(k) clearance and AI/ML-based features

Proven experience in regulatory submissions for invasive Class III or higher class devices such as catheters, and for systems and accessories.

서류전형 – 면접(실무-글로벌-부사장/HR : 3차면접) – 최종합격