BD (Becton, Dickinson and Company) Regulatory Affairs, Specialist/Sr. Specialist(Hybrid) in Osaka, Japan
Job Description Summary
Regulatory 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 Location
JPN Tokyo - Minato-ku
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.