Varian Medical Systems Korea, a Siemens Healthineers Company
South Korea
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Develop regulatory strategies
Prepare and submit regulatory dossiers
Medical device importer obligations
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Varian Medical Systems Korea, part of Siemens Healthineers, is seeking a Senior Regulatory Affairs Professional to develop regulatory strategies and ensure compliance for medical devices in South Korea. The role requires experience in high-risk medical devices and involves managing regulatory submissions, quality assurance responsibilities, and post-market activities.
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Job Summary
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing.
Matching Summary
Match Score: 75
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Varian Medical Systems Korea, part of Siemens Healthineers, is seeking a Senior Regulatory Affairs Professional to develop regulatory strategies and ensure compliance for medical devices in South Korea. The role requires experience in high-risk medical devices and involves managing regulatory submissions, quality assurance responsibilities, and post-market activities.
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Skills & Requirements
Must-have
Develop regulatory strategies
Prepare and submit regulatory dossiers
Medical device importer obligations
KGMP/ISO 13485 compliance
Monitor South Korean regulatory requirements
Product lifecycle regulatory input
Post-market regulatory activities
Adverse event reporting
Nice-to-have
Inspiring and caring environment
Global community
Professional and personal growth
Unique contributions
Familiarity with Digital Medical Products Act
Key Requirements
Korean native or native level Korean speaker
Bachelor’s degree or equivalent in a related field or 5 years of relevant experience
Experience in high-risk medical device (Class III)