Join a global leader in medical devices as a Quality Assurance Specialist focused on post-market product safety and compliance. In this role, you will monitor product performance, liaise with regulators, coordinate corrective actions, and work with global teams to ensure the highest standards of patient safety and regulatory adherence. This is a unique opportunity to make a meaningful impact on healthcare outcomes while building your career in a respected medical technology company.
Key Responsibilities
- Evaluate safety data and product performance to determine necessary risk mitigation.
- Collaborate with internal teams, regulatory authorities, and external stakeholders to ensure timely implementation of safety measures.
- Develop and maintain procedures for safety information collection, assessment, and follow-up actions.
- Review and update product labeling and instructions for use based on safety findings.
- Share local safety and complaint information with global manufacturers and support investigations.
- Contribute safety expertise to post-market studies and company-wide projects.
Required Skills and Qualifications
Experience:
- Minimum 3 years in quality assurance or safety management within the medical device sector.
- Proven ability to handle interactions with regulatory authorities and government officials.
- Strong English communication skills, including ability to participate in global teleconferences.
Language Requirements
- Japanese: Fluent (required for regulatory and local collaboration).
- English: Conversational to business level.
Preferred Skills & Attributes
- Knowledge of post-market surveillance, complaints handling, and safety reporting processes.
- Understanding of corrective and preventive action (CAPA) procedures; auditing experience is a plus.
- Strong analytical, problem-solving, and documentation skills.
- Ability to collaborate effectively across cross-functional teams and external stakeholders.
About the Company
Our client is a global innovator in medical technology, providing advanced solutions in cardiology, electrophysiology, urology, and endoscopy. Their technologies improve the lives of millions worldwide every year. With a strong focus on collaboration with healthcare professionals, they continue to deliver breakthroughs that enhance patient care and outcomes.
Why You'll Love Working Here
- Be part of a market-leading medical device company.
- High visibility and collaboration with global and regional leadership.
- Opportunity to work across international functions and markets.
- Join a respected medical community where your expertise is valued.
- Enjoy strong benefits, flex time, and remote work options.
Don't Miss Out - Apply Now!
