Regulatory Affairs Specialist / 診断薬
|職務内容||〇 Lead product registration projects and create registration documents in accordance with PMDAct.
〇 Create and apply reimbursement document. Support preparing reimbursement documents and obtaining reimbursement.
〇 Review and approval product labeling and other related material to ensure consistency with labeling included in registration documents.
〇 Evaluate and take necessary actions to Change Notifications.
〇 Help establish SOPs and work instructions.
〇 Help conduct for training on SOPs, Work Instructions, PMDAct, and other applicable laws and regulations
〇 Internal consultation based on PMDAct including regulatory determination and support the team of the expertise area
〇 Business Units: closely aligned with business unit(s), understand business priorities, keep business informed of RA strategy, progress, and resolve issues
〇 BDX Regulatory: obtain product information required for product registration in Japan. Input Japanese requirement to global team.
〇 LM: Request to obtain FMR and QMS inspection submission in align with product registration.
〇 QM: provide required regulatory actions for product changes
〇 PMDA: submit Shonin and Todoke to PMDA, and manage inquiries from PMDA
〇 Third party reviewer: submit Ninsho to the reviewers and manager their inquiries.
〇 External Trade Association: be sensing, monitoring, and influencing as a part of industrial association.
|応募資格||〇 More than 5 years’ experience regulatory affairs for In-vitro Diagnostics.
〇 Experience in Medical Device is also a plus.
〇 Business level English, written (mandatory) and spoken (preferable).
〇 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.
〇 Strong listening and assessment skills.
〇 Strong questioning & problem-solving skills.
〇 Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
〇 Doctor or Master's degree in Science is preferable but not mandatory