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Medical Device Compliance Specialist
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We are seeking a Medical Device Compliance Specialist to join our team at Guided Solutions. In this role, you will be responsible for ensuring the quality and safety of our Class 3 medical devices.
You will have a deep understanding of regulatory requirements, including FDA Quality System Regulations (QSR), ISO 13485 standards, and other global regulations and standards.
- Responsibilities:
- Evaluate and maintain compliance with regulatory requirements, including FDA QSR, ISO 13485, and other applicable global regulations and standards.
- Develop, implement, and maintain a quality management system (QMS) that meets regulatory requirements.
- Conduct audits and assessments to ensure compliance with regulatory requirements.
- Maintain accurate and detailed documentation, including device master records, design history files, and quality records.