A global leader in medical device innovation is seeking a Senior Specialist in Safety Vigilance to manage product safety compliance and post-market surveillance activities in Japan. This critical role ensures adherence to medical device and pharmaceutical regulations, coordinates safety reporting, and serves as the communication bridge between internal teams, manufacturers, and regulatory authorities. Your contributions will directly impact patient safety and regulatory excellence.
Key Responsibilities
- Ensure compliance with relevant laws and safety regulations for medical devices and pharmaceuticals
- Report adverse events and safety information to regulatory bodies accurately and within required timelines
- Manage product complaints and investigations with external manufacturers
- Track and process safety-related information using internal databases and tools
- Collaborate with internal stakeholders to address customer concerns and align project workflows
- Lead effective cross-functional communication to streamline issue resolution and reporting
- Handle communication with regulatory authorities and industry stakeholders to ensure regulatory alignment
Required Skills and Qualifications
- Minimum 3 years of experience in quality assurance or safety vigilance in the medical device or pharmaceutical industry
- Deep knowledge of GVP, QMS, and local regulatory frameworks for post-market safety
- Strong communication and business writing skills in both Japanese and English
- Proficient in Microsoft Excel, including VLOOKUP and pivot tables
- Ability to learn and adapt to internal tools and safety data systems
- Excellent cross-functional coordination and stakeholder engagement skills
Language Requirements
- Japanese: Native
- English: Business level
Preferred Skills & Qualifications
- Experience working with global teams and manufacturers
- Prior experience in managing audits or responding to health authority inquiries
About the Company
This foreign-owned medical technology company is globally recognized for delivering innovative surgical and neurotechnology solutions. Operating in over 70 countries and impacting more than 150 million lives annually, the company continues to push the boundaries of patient care. Employees benefit from a collaborative culture, career mobility, and flexibility, contributing to consistently high employee satisfaction.
Why You'll Love Working Here
- Work for a global leader in medical device innovation
- Collaborate with regional and international safety and QA teams
- Gain high visibility in regulatory operations with direct patient impact
- Enjoy remote work, flex time, and structured global benefits
- Be part of a mission-driven team focused on regulatory excellence and safety
Don't Miss Out - Apply Now!
