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.
Job Description SummaryRegulatory Affairs staff for BD/Medicon's products
- 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.
- 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 LocationJPN Osaka
Additional LocationsJPN Tokyo - Minato-ku
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.
- 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.
At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.
Staff Regulatory Affairs Specialist
I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.
Global Regulatory Operations Labeling Specialist
I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.
Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist