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.
- 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)
- 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)
- 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.