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 SummaryWho We Are
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.
Purpose: Work as a part of Regulatory Affairs team, supporting Becton Dickinson and Medicon medical devices.
- 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.
- 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.
- Strong interpersonal skills required in the areas of verbal and written communications, focus on regulatory bodies, appropriately responsive to service to internal business needs, coaching, influencing, and team building with growth mindset.
- Strong listening and assessment skills.
- Strong questioning & problem-solving skills.
- Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
- Experience of class III / IV medical device submission with clinical data is highly regarded. (Not essential)
Culture and Benefits
Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.
How To Apply
Submit your application by clicking on the “apply” button at the top of the page.
Primary Work LocationJPN Osaka
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