US Oncology Liquid Biopsy (NGS) Kit & Software start-up

Support regional regulatory activities for IVD/CDx medical device market access initiatives. This role is responsible for ensuring compliance with relevant local regulations during product realization and throughout the active distribution and post-market lifecycles.
Provide international regulatory strategy, timelines, and direction to US based development projects
Operate as the primary contact with local health authorities to process change notifications, supplements, and other market access applications
Create a local presence with health authorities via regular cadence of interactions

2+ years of IVD or 5+ years of relevant medical device experience
4+ years of regulatory domain experience
Global regulatory submission experience preferred
Experience with global health authority interactions and notified bodies

Entrepreneurial, driven to create
Ability to work in a fast-paced and dynamic environment
Strong communication and presentation skills
English & Japanese fluency required with additional APAC languages strongly preferred
Ability to be impactful and influence peers remotely
Self-starter