Designs and improves Global IT performance management, defines KPIs, monitors results, reports to leaders, identifies gaps, and supports efficiency, goal-setting, and budget activities.
About this role
The role leads a Quality Assurance and Regulatory Affairs team monitoring new and revised medical-device regulations and standards worldwide. It assesses effects on products and quality management systems (QMS), supporting compliance across products and internal processes with global stakeholders.
The leader sets monitoring plans, evaluates information sources, assigns work, and directs impact assessments and conformity activities. The role explains requirements to colleagues in Japan, the United States, Europe, and other regions, resolves escalated issues, coaches members, and improves processes through IT systems and AI. It may support compliance from early new-product development.
Applicants need at least five years of medical-device regulatory or registration experience; pharmaceutical, IVD, or diagnostic-device experience is also accepted. Required qualifications include expertise in medical-device regulations and standards, product registration or certification, procedure writing and guidance for other departments, and multi-stakeholder coordination. English document reading and writing and facilitation of internal English meetings are required.
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