Our client is a global leading life science manufacturer specialising in surgical microscopes. They are currently looking for a RAQA Manager in Japan to act as the "Sokatsu" for their business and to also lead the team in Japan.
Responsibilities:
- Regulatory Compliance: Ensure products and processes comply with Japanese regulatory requirements and the Quality Assurance Agreement.
- Regulatory Strategy: Develop and communicate regulatory strategies for new products to secure timely approvals in Japan.
- Stakeholder Engagement: Build and maintain relationships with government agencies and internal stakeholders; train associates on regulatory requirements.
- Continuous Improvement: Utilize CAPA and Lean Management tools to maintain high standards of process and product quality, and comply with company EHS requirements
Qualifications:
- Bachelor's degree in engineering or Life Sciences.
- At least 5 years of experience in Regulatory Affairs and Quality Assurance within Medical Device companies in Japan
- More than 3 years in a leadership role.
- Strong problem-solving and communication skills
- Native Japanese and fluent English, both spoken and written.
If you are interested, please apply with your CV attached.
