Position Summary
The Regulatory Affairs Specialist is responsible for ensuring DemeTECH Corporation complies with the regulatory requirements of FDA, ISO, EU MDR, Health Canada, CFDA, and other applicable authorities. This role leads pre-market and post-market regulatory activities including 510(k) and Technical Documentation submissions, PMS reporting, UDI compliance, and sterilization documentation. The position is also responsible for cross-functional regulatory guidance, audit preparation, and international market registration.
Key Responsibilities
Minimum Education Requirements
Required Competencies & Qualifications
Desirable Attributes
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