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. The role involves preparing product-related regulatory submissions and managing the regulatory strategy.

Key responsibilities

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

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 effectively across all levels and escalate issues proactively.
• Proficiency in spoken and written English.