Regulatory Affairs Manager

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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