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
I. OVERVIEW OF THIS POSITION
The Regulatory Affairs Specialist is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements in Korea .
To support/ conduct all necessary registration activities in compliance with related regulations in worldwide as well as Korea.
II . DUTIES PERFORMED
1. Regulatory Work
- To perform/coordinate successful submissions and approval of products including IVD in accordance with IVD Act;
- To review ACR (Assessment Change Requirement) to maintain product licenses in Regulatory compliance;
- To monitor and analyze new and revised regulation to verify business impact;
- To communicate potential risks and mitigations associated with regulatory strateties to stakeholders.
2. Compliance Work
- To support launching products regulatory review of label and IFU artworks and promotional materials;
- To review Research Use Only(RUO) reagents in accordance with K-REACH prior to import to Korea.
III . REQUIREMENTS
- B.S. or B.A. degree in biology, microbiology or bioscience (Science background will be preferred)
- New or Experienced (over 2yr experience in RA is preferred)
- Good at writing and translation skill in English
- Communicate clearly and effectively in both Korean and English
- Good social skills and ability to work in teams
- Proficiency with standard Windows and Office programs
※ Veterans and persons with disabilities are given preferential treatment in accordance with relevant laws.
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.