RA manager
Core
Lead regulatory strategy and compliance for imported IVDs, medical devices, and research reagents in the Japanese market, ensuring adherence to the PMD Act and managing post-market activities.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory-compliant product launches and post-market safety procedures for Thermo Fisher Diagnostics K.K.
Domain
Healthcare diagnostics and medical devices in Japan
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Japanese regulatory framework expertise, PMD Act knowledge, risk assessment, stakeholder negotiation, team leadership, regulatory submission preparation, license management, change control assessment, clinical study protocol input, audit support, regulatory change monitoring
Responsibilities
Develop and execute regulatory strategies aligned with business plans; establish communication with domestic and international stakeholders for regulatory submissions; provide guidance and mentorship to team members; collaborate on resolving recalls and Field Safety Notices; prepare and review regulatory submission documents and labeling materials; ensure timely renewal of licenses and registrations; communicate with regulatory authorities (MHLW, PMDA); manage product change control processes; provide input on clinical study protocols; support inspections and audits; monitor regulatory changes and propose compliance actions
Seniority
Senior, hands-on IC with team management
