Quality and Regulatory Compliance Expert
6 days ago
Job Summary:
We are seeking a Quality and Regulatory Specialist with extensive experience in quality management and regulatory compliance to join our team. The ideal candidate will have a strong background in managing quality systems, leading compliance initiatives, and conducting root cause analysis.
- Key Responsibilities:
- Manage the Quality Management System (QMS) to ensure efficiency and compliance with company procedures and related standards.
- Lead QMS compliance with internal procedures and external regulations, including 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR.
- Conduct Corrective and Preventive Action (CAPA) investigations from issue identification through to root cause analysis, resolution, and effectiveness checks.
- Analyze trends in non-conformances and CAPA data to identify systemic issues and contribute to continuous improvement initiatives.
- Provide essential quality and regulatory support throughout the medical device lifecycle, including managing documentation for Software as a Medical Device (SaMD).
- Maintain a foundational understanding of Information Security Management System (ISMS) and ensure the company's QMS and product documentation adhere to relevant security and privacy laws and regulations.
- Work closely with cross-functional teams to uphold a consistent and compliant approach to quality.
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