Senior Regulatory Affairs Specialist - PMDA & Oncology Dx
About the job
A global leader in precision medicine is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy for innovative oncology diagnostics in Japan. This role is ideal for a regulatory professional with strong experience in PMDA submissions, agency negotiations, and Japan-specific medical device regulations. You will play a critical part in accelerating approvals for advanced diagnostic software and medical devices, ensuring life-changing healthcare technologies reach patients faster.
Key Responsibilities
- Develop and execute regulatory plans to ensure new medical products align with business goals and approval timelines
- Lead the preparation and submission of high-quality regulatory documents to Japanese health authorities for product approvals
- Negotiate directly with the PMDA and other government agencies to secure timely approvals and manage product changes
- Partner with clinical and R&D teams to advise on regulatory risks, requirements, and compliance strategies
- Monitor regulatory updates, scientific trends, and new laws to support proactive compliance and long-term planning
Required Skills and Qualifications
Experience:
- Bachelor's degree or higher in science or engineering
- 5+ years of experience in regulatory affairs or clinical research
- Experience managing official submissions for medical device approvals and quality systems
- Strong understanding of Japan medical device regulations and requirements
Soft Skills:
- Clear communication and ability to collaborate across global and cross-functional teams
- Strong negotiation skills to work effectively with regulatory agencies under deadlines
- Highly organized with the ability to manage multiple priorities in a fast-paced environment
Language Requirements:
- Japanese: Native-level fluency
- English: Intermediate to Business-level proficiency (professional speaking and writing required)
Preferred Skills & Qualifications
- 3+ years of experience with oncology diagnostics, cancer testing, or medical software
- Experience with companion diagnostics and genomic profiling strongly preferred
- Knowledge of molecular technologies and clinical test interpretation is a plus
About the Company
Our client is a global precision medicine company specializing in advanced diagnostic technology. Using high-tech blood analysis and data science, they help healthcare providers detect serious diseases earlier and personalize treatment decisions. Their mission is to improve patient outcomes worldwide through non-invasive testing and highly detailed genetic insights.
Why You'll Love Working Here
- Work at the forefront of healthcare innovation, bringing advanced oncology diagnostics to Japan
- Play a key role in enabling faster access to critical medical technologies through strategic PMDA engagement
- Collaborate with international experts and top regulatory authorities to build a strong global RA career
- Flexible working style including remote work/WFH and flex time
- Meaningful impact in a mission-driven company focused on improving patient lives
Don't Miss Out - Apply Now!