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
Responsible for Imported BDI_PI Products Regulatory AffairsJob Description
KEY RESPONSIBILITIES（主要职责）
Maintain current NMPA approved certificates, including extension registration, change registration and support BU&RC to resolve post-marketing issues.
Make charge of new products launch in China, including make strategy, control registration timeline, type test, prepare registration documents, following evaluation and get approval.
Host regular meeting with WW to get requested documents and update registration status.
Follow NMPA regulations and analysis impacts to BD or responsible products. Other affairs within the team.
SKILLS AND ABILITIES（技能）
Medical/Pharmacy background, relevant experience on regulatory affairs
Bachelor degree or above
At least 2 years of regulatory affairs experience
Proficient in spoken and written English and Chinese
Ability to work independently and experience in a team on multiple projects Excellent interpersonal and communication skills
DESIRABLE（优先条件）
Medical device company working experience
Overseas education background
Required Skills
Optional Skills
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Primary Work Location
CHN BeijingAdditional 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.