International Regulatory Affairs Specialist II – Electrophysiology (on-site)
Core
Prepare and review regulatory documentation for international market entry (primarily China) of electrophysiology medical devices.
Role type
Specialist-level Regulatory Affairs professional
Builds
Regulatory submissions and compliance documentation for medical device product launches
Domain
Healthcare / Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory application preparation, medical device regulation review, submission timeline management, regulatory impact assessment, label compliance review, cross-functional collaboration
Preferred skills
NMPA (CFDA) regulatory experience, Chinese/Mandarin language proficiency, Master's degree, RAC certification
Technologies
Regulatory submission databases
Responsibilities
Assist in preparation of regulatory applications for China, review applicability of medical device regulations, determine submission requirements and timelines, evaluate changes for regulatory submission strategies, track deliverables to meet timelines, provide regulatory impact assessments, act as regulatory representative for guideline analysis, support product release process
Seniority
Specialist, hands-on IC