Ragulatory Affairs Coordinator (1yr, Contractor)

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

Key Responsibilities:

• Support preparation and compilation of documents for medical device regulatory submissions in Korea.

• Coordinate regulatory documentation and information with Global/Regional RA teams and relevant internal stakeholders.

• Support product registrations, post-approval changes, amendments, renewals, and other license maintenance activities.

• Track regulatory submissions, approvals, licenses, expiration dates, and key regulatory milestones.

• Maintain accurate and up-to-date regulatory files, databases, trackers, certificates, and approval records.

• Support regulatory change assessments and implementation activities under the guidance of RA team members.

• Assist in preparing documentation and information required for internal/external audits, inspections, and other compliance-related activities.

• Support monitoring and organization of information related to the regulatory and healthcare policy environment.

• Provide coordination, documentation, and administrative support for relevant Public Affairs activities and initiatives, as needed.

• Collaborate with internal and external stakeholders to support regulatory and related business activities.

• Support special projects, assignments, and other activities designated by the manager based on business and organizational needs.

Qualifications

Education and Experience:

• Bachelor's degree is required
• Entry-level or approximately 1-3 years of relevant experience in Regulatory Affairs, medical devices, pharmaceuticals, healthcare, or a related field preferred.

• Basic understanding of Korean medical device regulatory requirements and regulatory processes preferred.

• Strong documentation, organizational, and coordination skills.

• Detail-oriented with the ability to manage multiple tasks and priorities.

• Good written and verbal communication skills in Korean and English.

• Proficiency in Microsoft Office applications.

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.

Required Skills

Optional Skills

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Primary Work Location

KOR South Korea - Seoul HQ

Additional Locations

Work Shift