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Job ID R-546408 Category Regulatory Affairs Location Seoul, South Korea

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Job Summary

The RAPA Manager at Becton Dickinson Korea Limited will lead and manage the Regulatory Affairs and Public Affairs (RAPA) functions. This role ensures compliance with all relevant local and international regulations for medical devices. It is critical for safeguarding product quality, patient safety, and market access in Korea. You will join a skilled team committed to maintaining world-class standards and driving continuous improvement.

Job Responsibilities

• 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.

Job 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.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

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Primary Work Location

KOR South Korea - Seoul HQAdditional Locations

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