International Regulatory Affairs Specialist II – Electrophysiology (on-site)
Core
Prepare and review regulatory documentation for international product registration, primarily focusing on China, to ensure compliance with medical device regulations.
Role type
Specialist-level Regulatory Affairs Specialist
Builds
Regulatory submissions and product market entry for electrophysiology devices
Domain
Healthcare / Medical Devices / Regulatory Affairs
Required skills
Regulatory application preparation, regulatory compliance analysis, submission timeline management, regulatory impact assessment, cross-functional collaboration, document review
Preferred skills
Medical device industry experience, NMPA (CFDA) familiarity, Chinese/Mandarin language proficiency, 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 preclinical and clinical changes for regulatory strategy, track deliverables, provide regulatory impact assessments, act as regulatory representative for guidelines, support label development and product release processes.
Seniority
Specialist, hands-on IC