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About the Role

As a Regulatory Affairs Specialist/Senior Specialist, you will be responsible for the entire product lifecycle of medical devices (Class I-IV), from approval strategy to post-market management. You will participate in projects from the early development stages, leading market launches in line with business strategy while ensuring compliance. This position is also open to those who wish to leverage their experience in R&D, product development, or QA in the regulatory affairs field. You will expand your expertise based on skills in reading and understanding research, logical organization, and documentation.

Responsibilities

Create, review, and submit regulatory submission documents for medical devices (Class I-IV) (e.g., approval applications, supporting documents, QMS conformity investigation applications).
Liaise with the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare, and respond to inquiries.
Develop regulatory strategies from the product development stage and manage submission schedules.
Manage post-market regulatory maintenance (e.g., minor change notifications, amendments, periodic reports).
Monitor regulatory trends and disseminate information internally.
Develop SOPs and conduct internal training.
Collaborate with the overseas headquarters and global teams.

Requirements

Bachelor's degree or higher in a life science field or related area.
Excellent communication, negotiation, and presentation skills.
Logical thinking and problem-solving abilities.
Proactive and responsible approach to work.
Japanese: Native level, English: Business level.

Skills

Regulatory Affairs
Medical Device Regulations
QMS
GCP
Project Management

Location

Tokyo, Minato-ku, Japan

Work Type

Full-time

Experience Level

Specialist
Senior Specialist

Education Level

Bachelor's degree or higher in a life science field or related area.

About the Company

BD is one of the largest global medical technology companies in the world.
Advancing the world of health™ is our Purpose.
We create medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum.
Our mission is 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.

Equal Opportunity

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.