Regulatory Affairs Specialist / Senior Specialist

About the role

This position is part of Varian Medical Systems Korea and works closely as one team with Siemens Healthineers. It covers regulatory submissions and compliance for medical devices in South Korea, with support for the Mongolia market.

Key responsibilities

• Analyze requirements and prepare product-related regulatory submissions
• Develop regulatory strategies and handle the preparation and submission of dossiers for new registrations, variations and supplements
• Oversee QA-related duties, including medical device importer obligations, KGMP/ISO 13485 compliance and internal and external audits
• Monitor regulatory requirements in South Korea, explain their impact to management and teams, and ensure compliance
• Collaborate with internal teams throughout the product lifecycle to prevent regulatory gaps and speed up registration and launch
• Identify regulatory risks early and propose mitigation strategies
• Review product labeling, packaging and promotional materials for compliance with local regulations and company policy
• Manage post-market activities such as adverse event reporting, product recalls, CAPA and post-market surveillance
• Represent the company in government and industry meetings, forums, audits and lobbying
• Lead process improvements for regulatory operations in South Korea and support regulatory compliance for Mongolia

Required profile

• Bachelor's degree or equivalent in a related field, with 4 years of relevant experience
• Experience with high-risk medical devices (Class III) under the Medical Device Act
• Experience with KGMP onsite audits
• Familiarity with the Digital Medical Products Act (DMPA) is a plus
• Able to manage projects with attention to detail, communicate across all levels and escalate issues proactively
• Proficiency in spoken and written English