BD (Becton, Dickinson and Company) Specialist, Regulatory Affairs in Osaka, Japan
Job Description Summary
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.
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.
[Additional Desirable Qualifications Skills and Knowledge ]
Experience of class III / IV medical device submission with clinical data is highly regarded. (Not essential)
Experience of Electronic medecial device submission
Primary Work Location
JPN Tokyo - Minato-ku
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. 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.