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
Job Description Summary
Job Description
P2-14313
- Mainly Product License Approval for new and amendment on time
- Prepares regulatory documents for product submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of medical devices, instrument. Assures adequate documentation exists for product claims and directs timely review of regulatory documents.
- Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics
- Strategic communication skill and ability with team, MFDS officer and Business partner
- Strategic and meticulous mindset is preferred
- Minimum 4~7 years prior experience working on product regulatory submissions.
- Fully understand new and revised Medical device Act
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
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.