Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Location: Seoul, Korea

Our client is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and exceptional quality. They are committed to compliance with global regulatory standards and are seeking a talented Regulatory Affairs Manager to join the team.

Key Responsibilities:

• Regulatory Strategy: Develop and implement regulatory strategies to ensure timely approval of medical devices in Korea and other target markets.
• Submissions: Prepare, review, and submit regulatory documents, including pre-market notifications, technical files, and clinical trial applications to regulatory authorities such as the Ministry of Food and Drug Safety (MFDS).
• Compliance: Ensure compliance with local and international regulations, standards, and guidelines, including ISO 13485, MDR, and FDA requirements.
• Liaison: Act as the primary contact with regulatory agencies, managing communications and negotiations to facilitate approvals and resolve issues.
• Documentation: Maintain and update regulatory documentation, including product registrations, labeling, and promotional materials.
• Training: Provide training and guidance to internal teams on regulatory requirements and changes in the regulatory landscape.
• Audits: Support regulatory inspections and audits, ensuring readiness and compliance.

Requirements:

• Education: Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering, Pharmacy) or related field.
• Experience: Minimum 5 years of experience in regulatory affairs within the medical device industry, with a strong understanding of Korean and international regulations (US FDA, etc.).
• Skills: Excellent written and verbal communication skills in both Korean and English. Strong analytical and problem-solving abilities.
• Knowledge: In-depth knowledge of regulatory requirements and standards, including ISO 13485, MDR, and FDA regulations.
• Language Proficiency: Fluent in both Korean and English languages.