QAスペシャリスト（Product Compliance）
Core
Ensures regulatory compliance for research instruments and reagents by managing domestic regulations, creating labels/SDS, and handling customer inquiries.
Role type
Product Compliance Specialist (Regulatory Affairs)
Builds
Regulatory compliance documentation, safety data sheets, and certified product releases for research tools and reagents.
Domain
Life Sciences / Chemical Safety / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance knowledge (Poisonous/Infectious Substances Act, PSE, etc.), SDS/GHS label creation, customer inquiry handling, process improvement, training material development
Preferred skills
Mechanical safety knowledge, team leadership experience, ERP system usage (SAP, TrackWise, SFDC), ISO knowledge, manufacturer HQ QA experience
Technologies
SAP, TrackWise, SFDC
Responsibilities
Investigate and manage domestic product regulations, create and revise GHS labels and SDS, handle customer inquiries, issue certificates, conduct training and process improvement
Seniority
Mid-level IC (Band 5, no direct reports)
