Principal Specialist, Regulatory Affairs

勤務地 東京都
業界・業種 医療・製薬
契約タイプ Permanent
給料 Negotiable
参照番号 55783

Regulatory Affairs & Post-Market Safety Manager (IVD / Medical Devices)

Position Overview

This role is responsible for obtaining timely regulatory approvals for new and existing in vitro diagnostics (IVD) and medical device products through direct interaction with Japanese regulatory authorities.
You will also oversee post‑market safety (PMS) activities, ensuring compliance with local safety, quality, and reporting requirements throughout the entire product lifecycle.

As a key internal authority on regulatory and safety matters, the role collaborates closely with cross‑functional teams to manage regulatory submissions, quality events, and governance obligations in accordance with Japanese regulations, industry standards, and internal policies.

Key Responsibilities

  • Serve as the Responsible Person for post‑market safety management of IVD and medical device products, ensuring full regulatory compliance

  • Collaborate with internal teams to manage product quality issues, including complaint handling and field safety actions (e.g., recalls)

  • Maintain and update post‑market safety documentation in alignment with regulatory changes

  • Support and manage required licenses, registrations, and renewals related to medical devices and diagnostics

  • Lead the preparation of technical regulatory dossiers and manage communication with regulatory authorities, including responses to inquiries

  • Organize and facilitate internal regulatory and safety meetings to ensure timely cross‑functional communication and alignment

Skills & Experience

  • Licensed pharmacist qualification (必須)

  • Extensive experience in regulatory affairs within medical devices, diagnostics, or life sciences

  • People management experience preferred

  • Strong English communication skills and ability to work effectively across cross‑functional teams

  • Deep understanding of the healthcare business environment with strong leadership and project management capability

  • Proficiency in Microsoft Excel and PowerPoint

  • Experience with Japanese regulatory submission systems is a plus

Additional Information

  • Minimal travel required (less than 10%)