Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
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 maintenance of product labeling materials, including labels, IFUs (Instructions for Use), and related regulatory documentation.
- Download, organize, and maintain previously submitted regulatory registration dossiers and supporting documents.
- Manage regulatory filing documentation, electronic records, and document uploads within designated systems and repositories.
- Prepare basic regulatory application forms, administrative documents, and supporting materials for regulatory submissions.
- Maintain product registration databases and ensure regulatory records remain accurate, complete, and up to date.
- Assist in tracking and prioritizing regulatory submission timelines, approvals, renewals, and regulatory commitments.
- Support implementation of document management improvements and process optimization initiatives associated with APM Integration activities.
- Prepare meeting materials, maintain action trackers, and support project documentation for regulatory and integration initiatives.
- Provide administrative and operational support to ensure efficient and compliant regulatory operations.
- Perform additional duties and special projects as assigned.
Qualifications
Education
- Bachelor's degree in Life Sciences, Pharmacy, Biology, Biomedical Engineering, Healthcare, or a related field.
Experience
- 1-3 years of experience in Regulatory Affairs, Quality, Medical Device, Pharmaceutical, Healthcare, or a related industry preferred.
- Experience in project coordination, system implementation, document management, or integration projects is an advantage.
- Familiarity with Korean medical device regulations is preferred.
Skills & Proficiencies
- Strong communication and stakeholder management skills.
- Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
- Experience with regulatory information management systems (RIM), document management systems, SAP, or similar platforms is advantageous.
- Ability to work effectively across cross-functional and multicultural teams.
- Fluent Korean and business-level English, both written and verbal.
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 HQAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter