BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Tokyo, Japan

Job Description Summary

To obtain premarket product registration/approval in Japan in align with BDJ-RA Mission and Vision.

Job Description

Responsibilities

  • Lead product registration projects and create registration documents in accordance with PMDAct.

  • Create and apply reimbursement document for A & B. Support preparing reimbursement documents for C and obtaining reimbursement.

  • Review and approval product labeling and other related material to ensure consistency with labeling included in registration documents.

  • Review and approval product labeling and other related material to ensure consistency with labeling included in registration documents.

  • Help establish SOPs and work instructions.

  • Help conduct for training on SOPs, Work Instructions, PMDAct, and other applicable laws and regulations

  • Internal consultation based on PMDAct including regulatory determination and support the team of the expertise area

Engagement

  • Business Units: closely aligned with business unit(s), understand business priorities, keep business informed of RA strategy, progress, and resolve issues

  • BDX Regulatory: obtain product information required for product registration in Japan

  • LM: Request to obtain FMR and QMS inspection submission in align with product registration.

  • QM: provide required regulatory actions for product changes

  • PMDA: submit Shonin and Todoke to PMDA, and manage inquiries from PMDA

  • Third party reviewer: submit Ninsho to the reviewers and manager their inquiries.

  • External Trade Association: be sensing, monitoring, and influencing as a part of industrial association.

Primary Work Location

JPN Tokyo - Minato-ku

Additional Locations

Work Shift

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.