A global life sciences company is seeking a Quality Management Specialist to oversee post-market safety and regulatory compliance for medical and diagnostic devices. This role plays a critical part in maintaining quality standards, ensuring product safety, and supporting internal and external stakeholders through effective communication and quality systems management. You will help shape regulatory strategies and uphold compliance across APAC operations.
Key Responsibilities
- Manage post-market safety activities for diagnostic and medical devices in accordance with regulatory guidelines
- Communicate safety measures and regulatory updates to internal teams and external partners
- Handle customer complaints and quality issues, working closely with manufacturers
- Develop and maintain quality systems that align with QMS and internal protocols
- Monitor and report regulatory compliance across product lines and operations
- Partner with cross-functional teams to investigate safety concerns and ensure ongoing regulatory conformity
- Ensure compliance with chemical, environmental, and product safety regulations
Required Skills and Qualifications
- At least 3 years of experience in quality assurance, safety management, or regulatory affairs within the medical device or diagnostics industry
- Background in product development, design, or manufacturing processes
- Familiarity with QMS (Quality Management Systems), GVP, and other medical device regulations
- Bachelor's degree in chemistry, biology, pharmacology, engineering, or a related field
- Strong ability to structure technical content and prepare clear documentation
- Excellent self-management skills with the ability to take initiative and drive progress
- Business-level proficiency in English and native-level Japanese
Language Requirements
- Japanese: Native
- English: Business level
Preferred Skills & Qualifications
- Experience with regulatory inspections or audits
- Familiarity with global compliance standards and safety protocols
About the Company
This foreign-owned life sciences company provides innovative support to researchers, developers, and manufacturers across pharmaceuticals, diagnostics, and therapeutic solutions. With a strong global footprint and a mission to advance human health, the company specializes in accelerating drug discovery, gene and cell therapy innovations, and next-generation vaccines.
Why You'll Love Working Here
- Join a market-leading life sciences company with a global reputation
- Gain exposure to international QA and regulatory operations
- Collaborate with cross-functional teams across APAC and beyond
- Access flexible work arrangements, remote work options, and global benefits
- Be part of a mission-driven culture focused on patient safety and innovation
Don't Miss Out - Apply Now!
