A global leader in medical devices is seeking a Regulatory Affairs Lead to oversee approval applications, certifications, and compliance for medical devices in Japan. This role involves managing regulatory processes, PMDA applications, and compliance inspections, ensuring smooth approvals and renewals. If you have a strong background in regulatory affairs, experience in medical device applications (Class I-IV), and excellent communication skills, this is a great opportunity to drive compliance and innovation in the healthcare industry.
Key Responsibilities
- Independently manage approval applications and notifications for medical devices in compliance with PMDA and regulatory requirements
- Oversee manufacturing, distribution, and certification approval processes, including planning, data collection, and liaising with PMDA/NB
- Maintain regulatory approvals and certifications through change control and periodic renewals
- Handle QMS compliance inspection applications to ensure regulatory alignment
- Prepare and submit insurance listing applications, including documentation and form creation
- Collaborate with QC, Sales & Marketing, and Operations teams for efficient regulatory execution
Required Skills and Qualifications
Experience:
- At least 3 years of experience in medical device regulatory affairs
- Expertise in PMDA consultation and approval applications, particularly for Class IV medical devices
Soft Skills:
- Strong communication and project management skills to coordinate with internal and external stakeholders
- Ability to effectively collaborate with QC, Sales, and Operations teams
Language Requirements
- Japanese: Fluent (required)
- English: Intermediate to Business level
Preferred Skills & Qualifications
- Experience drafting business documents in English
- Proactive, results-driven approach with a high level of integrity
About the Company
A global leader in medical technology, specializing in surgical, neurotechnology, spine, and orthopaedic devices. The company impacts over 150 million patients annually by advancing healthcare solutions through cutting-edge medical innovation. Employees benefit from career growth opportunities, internal mobility, and a flexible work environment, leading to high job satisfaction and retention.
Why You'll Love Working Here
- Work with a global leader in medical technology
- Flexible work arrangements, including remote work and flextime
- Career development programs and internal mobility opportunities
- Comprehensive benefits, including paid leave, childcare leave, and social insurance
- Convenient office location less than 5 minutes from the station
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