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Regulatory Affairs Manager

Job Details

Location: Japan
Salary: Negotiable
Job Type: Permanent
Specialization: Pharmaceutical & Medical Device
Reference: BBBH41983_1671440540
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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.

If this position is not ideal for you, but you are looking for a new opportunity,please contact us to discuss your options.

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