Medical Device Clearance Specialist
6 days ago
Key Responsibilities
The Medical Device Clearance Specialist will be responsible for supporting the obtaining of medical device pre-market regulatory approvals and ensuring market access for Accuray products and services in Asia Pacific. Key responsibilities include:
1. Regulatory Submissions
- Prepare and submit regulatory applications required for product market approvals in Asia Pacific Region.
- Manage Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
2. Collaboration and Communication
- Collaborate with research personnel, application specialists, and risk management specialists to ensure clinical research and evaluations meet necessary regulatory requirements.
- Communicate effectively with Regulatory Agencies regarding recall activity.
3. Subject Matter Expertise
- Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
- Participate in quality system and design dossier audits as a subject matter expert.
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