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
Regulatory Affairs staff for BD/Medicon's productsJob Description
[Job description]
- Develop an effective regulatory strategy for each project from a broad perspective and achieve active product introduction.
- Develop logical thinking, simplify complex information and provide logical explanation
- Proactively advance each project with skills to deliver powerful, compelling messages while maintaining good communication with various parties at BD/Medicon, MHLW/PMDA and industries.
- Understand PMDA/MHLW’s thinking and successfully negotiate for the benefit of BD/Medicon and projects.
- Enhance internal compliance and risk management system based on understanding of the Japanese PMD Act and other business-related laws and regulations.
[Education requirement]
- Master's degree in Science (MSc)
[ Basic Qualifications & Required Experience ]
- More than 3 years’ experience of regulatory affairs for class I/ II/ III / IV medical devices in medical device company, or a Contract Research Organization (CRO).
- Business level English.
Primary Work Location
JPN OsakaAdditional Locations
JPN Tokyo - Minato-kuWork 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.