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
The Regulatory Affairs Coordinator is responsible for handling EU MDR project and NoCs.Job Description
Main Responsibilities
- Temporary hiring for EU MDR/IVDR and NoCs
- Communicates and aligns/supports with RA team and business, international RA folks, and other stakeholders on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay.
- Reviews the documents and prepares/submits for technical file/product approvals to the local authority.
- Monitors change notifications to analyze the impacts of the product license and completes proper actions for the changes
- Maintains and archives all the related documents for registration; maintain and regularly update the product master files.
- Prepares and maintains the product Korean labels/IFUs to meet local regulations and company procedures
- Translates the documents to submit the local authority
- Performs other activities assigned and/or instructed by direct manager
[Job Requirements
- Minimum of a Bachelor Degree in Biomedical Engineering, Biochemistry, Chemistry, Pharmacy, or related science
- Minimum 1 year prior experience working in Regulatory Affairs preferred
- Good English communication skills(writing and speaking)
Required Skills
Optional Skills
.
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.