Join a globally recognized healthcare leader as an RAQA Manager and drive regulatory and quality assurance excellence for advanced medical technologies. You'll lead cross-functional teams, manage regulatory submissions, and improve quality systems to ensure compliance and support innovation across Japan and international markets.
Key Responsibilities
- Enhance and streamline internal quality systems to improve compliance and operational performance
- Lead audit preparation and respond to internal and external inspections
- Manage technical documentation and regulatory submissions for new technologies
- Coordinate with production teams to ensure alignment on documentation and processes
- Analyze customer feedback and complaints to implement quality improvements
- Mentor team members and align departmental efforts with organizational goals
- Drive product improvement, compliance, and efficiency initiatives across functions
Required Skills and Qualifications
Experience:
- Minimum 3 years in a supervisory or managerial role within a regulated industry
- Strong knowledge of quality assurance systems, compliance, and regulatory processes
Technical Skills:
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Experience with quality systems and regulatory documentation
Soft Skills:
- Proven leadership and change management abilities
- Strong problem-solving skills with analytical thinking
- Effective communicator with global and cross-functional teams
Language Requirements
- Japanese: Fluent
- English: Intermediate to Business level
Preferred Skills & Qualifications
- Bachelor's degree or higher in science, engineering, or related technical field
- Experience working with international regulatory teams or on global submissions
About the Company
This global healthcare company has over 100 years of innovation and impact in medical devices. With operations in more than 100 countries, it is a trusted name among healthcare professionals worldwide. The company is known for its forward-thinking approach and commitment to excellence in diagnostics and treatment technologies.
Why You'll Love Working Here
- Be part of a market-leading global brand with strong recognition
- Collaborate with international teams and gain exposure to global leadership
- Contribute to high-impact healthcare innovation
- Enjoy comprehensive benefits and flexible remote work options
- Grow your career in a respected and inclusive medical community
Don't Miss Out - Apply Now!