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Regulatory Affairs Manager

仕事詳細

勤務地: 日本
給与: Negotiable
職種: 正社員
専門: Pharmaceutical & Medical Device
参照: BBBH41983_1671440540
No consultant assigned to this job.

Regulatory Affairs Manager/ Global implantable hearing leader

Position Overview / Purpose

The Regulatory Manager is accountable for the development and implementation of Japan's Regulatory and Reimbursement strategy.

Job responsibilities:

  • Strategic Planning- Define local regulatory strategies and develop functional business plans in collaboration with the RQR Director, and APAC Regulatory Managers.
  • Product Registrations- Establish and maintain strong relationships with PMDA and MHLW representatives to maintain visibility and engage dialogue regarding submissions in process.
  • Product Continuity- Define and communicate local product registration plans in line with sales and marketing expectations and champion Japan's regulatory requirements to support efficient and effective product development and market access.
  • Regulatory Compliance- Monitor changes in the regulatory environment,
  • Quality System Management
  • Team Development
  • Team Role (Manager of people)

Requirements:

  • Over 10 years' experience in Medical Device Regulatory Affairs or an equivalent field in Japan
  • Ability to collaborate and influence across the local (Japan) and HQ offices
  • Demonstrated experience in managing regulatory affairs tasks for preparation, implementation and execution of submissions within designated timeframes
  • Experience interacting directly with Regulatory Agencies and external providers to meet designated timeframes and maintain regulatory compliance
  • Native level Japanese and business level English (TOEIC score ≥780, desirable)

Ideal

  • Experience within the medical device industry in Japan (product registration of class III or IV)
  • Knowledge of Japanese Medical Device Law and the product registration process
  • Willing to lead the organization in the future as the Director of RQR, managing not only RA operations but also QA and safety management work.

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