RAPA Manager

Description

• Develop, implement, and maintain robust RAPA strategies and policies in alignment with global BD standards and local regulations.
• Coordinate all regulatory submissions, registrations, and approvals for new and existing products, including product variations and renewals.
• Manage and lead interactions with regulatory authorities (e.g., MFDS) and notified bodies, acting as the primary contact for regulatory matters.
• Provide expert RAPA mentorship and support to cross-functional teams, including R&D, commercial, and supply chain.
• Monitor and interpret changes in regulatory requirements and ensure timely implementation of updates across the organization.
• Lead, mentor, and develop the RAPA team, encouraging a culture of compliance, quality, and continuous improvement.
• Manage RAPA budgets and resources effectively.

Qualifications

• Bachelor's degree or equivalent experience in a scientific field (e.g., Pharmacy, Biotechnology, Biomedical Engineering) or related subject area. Master's degree preferred.
• Minimum of 10-12 years of experience in Regulatory Affairs, Public Affairs, and/or Pharmacovigilance within the medical device industry.
• Proven leadership experience with at least 3-5 years in a managerial role.
• In-depth knowledge of Korean medical device regulations (MFDS) and international standards (e.g., ISO 13485, MDSAP, ICH-GCP).
• Strong understanding of quality management systems and experience with internal and external audits.
• Demonstrated experience in managing regulatory submissions and interactions with health authorities.
• Excellent communication, negotiation, and interpersonal skills, with proficiency in both Korean and English (written and spoken).
• Strong analytical and problem-solving abilities.
• Ability to work effectively in a matrix organization and prioritize multiple priorities.