Advance your career with a global leader in precision oncology as a Regulatory Affairs & Quality Assurance Specialist. In this high-impact role, you will oversee both regulatory affairs and quality assurance for innovative oncology diagnostic devices in Japan. Working closely with Japanese health authorities and global cross-functional teams, you will play a critical role in ensuring regulatory compliance, maintaining quality standards, and supporting technologies that help improve cancer diagnosis and patient outcomes.
Key Responsibilities
- Prepare and submit regulatory applications while managing communications with Japanese health authorities throughout the approval process.
- Oversee the local Quality Management System (QMS) to ensure compliance with Japanese medical device regulations and global quality standards.
- Investigate product quality complaints and implement corrective and preventive actions (CAPA) to minimise safety risks and maintain product quality.
- Serve as the primary representative during government inspections, regulatory audits, and internal quality assessments.
- Review and approve quality documentation to ensure diagnostic products meet all regulatory requirements before commercial release.
Required Skills and Qualifications
Experience:
- 5+ years of regulatory affairs and quality assurance experience within Japan's medical device or in-vitro diagnostic (IVD) industry.
- Hands-on experience preparing regulatory submissions and managing consultations with Japanese regulatory authorities.
- Strong understanding of Japanese medical device regulations, quality management systems, and regulatory compliance.
- Ability to manage multiple regulatory and quality projects while maintaining exceptional accuracy.
Soft Skills:
- Excellent analytical skills with exceptional attention to detail.
- Strong communication skills with the ability to explain complex Japanese regulatory requirements to international stakeholders.
- Self-motivated and capable of working independently with minimal supervision.
- Highly organised and able to prioritise effectively in a fast-paced, dynamic environment.
Language Requirements:
- Japanese: Native level.
- English: Intermediate to Business level.
Preferred Skills & Qualifications
- Master's degree or PhD in a scientific discipline.
- Previous experience serving as a licensed Quality Responsible Person (Hinseki).
- Experience working within a Marketing Authorization Holder (MAH) quality management structure.
- Background in precision oncology, next-generation sequencing (NGS), medical device software, or advanced diagnostic technologies.
About the Company
Our client is a global precision oncology company dedicated to transforming cancer care through innovative diagnostic technologies. By combining proprietary blood-based testing, extensive genomic datasets, and advanced data analytics, the organisation enables healthcare professionals to make more informed treatment decisions. With a strong commitment to scientific innovation and patient outcomes, the company continues to shape the future of personalised cancer care worldwide.
Why You'll Love Working Here
- Take on a leadership role overseeing both Regulatory Affairs and Quality Assurance within an innovative global organisation.
- Work with cutting-edge oncology diagnostic technologies that directly contribute to improving patient care.
- Collaborate closely with Japanese regulatory authorities and international cross-functional teams.
- Competitive salary package of ¥8M-¥11M with flexible working arrangements, including remote work and flex-time.
- Join a mission-driven organisation at the forefront of precision medicine and life sciences innovation.
Don't Miss Out - Apply Now!
