The Regulatory Affairs Analyst develops strategies, evaluates product changes, prepares submissions, ensures compliance, supports inspections, and maintains KGMP certifications, requiring 5-6 years of medical device regulatory experience and strong communication skills.

• Develops regulatory strategies and assists in navigating the submission pathway
• Evaluates changes to existing products to determine the need for new registrations or license variations.
• Organizes renewal submissions based on business requirements to ensure business continuity
• Provides regulatory input throughout the product development cycle and ensures compliance with relevant standards.
• Collaborates with a cross functional team to achieve regulatory excellence.
• Reviews and approves marketing materials to ensure they align with approved claims and/or regulatory requirements.
• Evaluates the reportability of adverse events and performs post-market reporting in accordance with national regulations.
• Identifies issues affecting project progress and collaborates with management to propose solutions for project acceleration or correction.
• Keeps abreast new regulatory requirements and organize regulatory intelligence for impact assessment in South Korea.
• Fosters effective and transparent communication within the Regulatory Affairs team and with other relevant stakeholders and departments.
• Provides support during regulatory inspections and audits as needed such as ISO 13485, GIP, KGMP, etc.
• Ensures accurate documentation in accordance with Quality Management System (QMS) requirements.
• Develops and implements strategic plans for Korea Good Manufacturing Practice (KGMP) and oversees the maintenance of KGMP certifications.
• Coordinates with overseas manufacturing sites to obtain necessary KGMP documents and dossiers in a timely manner.

• Minimum 5-6 years working experience as regulatory affairs in medical device company
• Demonstrated proficiency with Business Tools such as MS Office word, excel, powerpoint applications.
• Bachelor's degree in science, engineering, medical or related subject
• Ability to communicate effectively in English (both written and oral).
• Korea MFDS experience is preferred
• Korea RA level 2 certification is preferred

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