Roche Diagnostics K. K.
Healthcare
RegulatoryAffairsSpecialist
“Regulatory Affairs Specialist at Roche Diagnostics K. K.. Skills: Regulatory affairs, Compliance, Medical devices, In vitro diagnostics. Develop regulatory strategy. Obtain and maintain approvals”
Industry & Context.
Logical thinking
What They're Looking For.
Must Have
3+ years regulatory affairs experience, Experience with self-directed work, Experience achieving results
Nice to Have
Experience with program medical devices
What You'll Do.
Develop regulatory strategy
Obtain and maintain approvals
Ensure patient access
Conduct PMDA consultations
Negotiate with authorities
Maintain regulatory compliance
Manage change control
Review packaging materials
How You'll Work.
Team & Collaboration
Cross-functional teams; Global regulatory team; Business teams; Medical teams; Quality management; Market access; Government affairs
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management
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