薬事部 スタッフ

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Job details

Company overview

Medical devices maker, specialized in artificial heart.

Responsibilities

The RA staff in this role plans, coordinates, and executes Regulatory Affairs activities for both new and existing products. Responsibilities include interpreting regulations, leading cross‑functional implementation of compliance measures, and communicating with health authorities in relation to regulatory submissions.
Main responsibilities:

• Actively participate in strategic discussions with cross functional team members.
• Plan regulatory activities for assigned projects.
• Serve as the primary person responsible for implementing regulatory activities for assigned projects, including:
  • Pre submission activities, including consultations with health authorities
  • Submission of applications/notifications to health authorities
  • Responding to inquiries from health authorities
  • Provide post approval support, including reimbursement notifications and copy review.
• Life cycle management (e.g., maintenance of licenses, change assessments).
• QMS compliance (including training and audit support) and other cross functional collaboration as required.

Requirements

Minimum requirements:

• More than 5 years of experience in regulatory affairs for medical devices.
• Comprehensive understanding of the Japanese PMD Act and associated regulations.
• Demonstrated leadership and communication skills, and English proficiency sufficient to lead internal regulatory discussions via conference calls for assigned projects.
• Proficient with standard PC applications (Microsoft Excel, Word, PowerPoint, PDF, etc.).

Preferred qualifications:

• Experience with registration of cardiovascular products.
• Experience in regulatory submissions using local/global clinical trial or evidence.

Salary

6 - 9 million yen

Location

Tokyo