Senior Regulatory Affairs Professional
Siemens Healthineers(2 months ago)
About this role
A Regulatory Affairs & Quality Assurance Manager supporting Siemens Healthineers’ medical device operations in South Korea and Mongolia. The role focuses on ensuring products meet local regulatory and quality system expectations and acts as the company’s local regulatory liaison. It works across functions to enable product registrations, market access, and compliance with applicable standards.
Required Skills
- Regulatory Strategy
- Dossier Preparation
- QA Management
- KGMP Compliance
- ISO 13485
- Auditing
- Regulatory Monitoring
- Collaboration
- Risk Management
- Labeling Review
+5 more
Qualifications
- Bachelor's Degree in Related Field
- 5 Years Relevant Experience
- Korean Native Speaker
About Siemens Healthineers
siemens-healthineers.comWe pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Discover more about our innovative medtech and the people behind it.
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