Post Market Surveillance Specialist
Integra LifeSciences · JP-JHQ-Tokyo-370-Facility
SafetyFull-timeCompany career page
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Role summary
Integra LifeSciences seeks a Post Market Surveillance Specialist in Tokyo to manage adverse event reporting, product complaints, and regulatory compliance activities for medical devices. The role involves coordinating with Japanese regulatory bodies, preparing documentation, and conducting risk assessments.
What they're looking for
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field
- Minimum 3 years post-market surveillance and GVP experience in medical devices
- Knowledge of Japanese medical device regulations, GVP, and QMS Ordinance
- Business-level English communication skills, written and spoken
- Proficiency with MS Word, Excel, and PowerPoint
- Strong organizational and problem-solving abilities with attention to detail
- Ability to manage multiple priorities in a fast-paced environment
What you'll be doing
- Execute GVP activities including adverse event and field safety corrective action reporting
- Manage product complaints and prepare investigation reports for customers
- Prepare and revise package inserts with PMDA and MHLW coordination
- Serve as primary contact for audits by Japanese regulatory authorities and Notified Bodies
- Conduct product risk assessments and internal audits
Privacy & handoff
This role links to Integra LifeSciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.