Specialist, Commercial QA
Core
Serve as the Safety Management Officer for medical devices and IVD products in Japan, ensuring compliance with PMD Act and GVP requirements while managing post-market safety and quality.
Role type
Specialist, Commercial Quality Assurance & Regulatory Affairs (RAQA)
Builds
Maintains quality and safety of marketed medical devices and IVD products for Radiometer in the Japanese market.
Domain
Life sciences, diagnostics, biotechnology, medical devices, IVD
Deliverable
client delivery
Required skills
Japanese pharmacist license, 5+ years in quality assurance/regulatory/safety management in medical devices or IVD, knowledge of PMD Act, GVP, ISO 13485, QMS regulations
Preferred skills
Experience as overall responsible person or safety management officer, team management and mentoring, global matrix organization experience, business-level English
Technologies
None
Responsibilities
Collect and manage safety information for products domestically and internationally; Lead or support responses to audits by PMDA and Tokyo Metropolitan Government; Execute CAPA to complete corrective actions; Monitor product quality performance and market feedback to analyze trends and report to global stakeholders; Collaborate with global R&D and manufacturing sites to identify root causes and drive design/process improvements; Review promotional tools and materials for regulatory compliance and safety; Conduct risk-based decision-making to foster a compliance culture.
Seniority
Specialist, hands-on IC
