We are seeking an experienced consultant with a strong background in combination products quality systems and clinical operations to support a focused remediation and compliance initiative. This project will involve a comprehensive review of existing Clinical Operations procedures and supporting documentation to assess alignment with combination product development requirements and applicable global regulatory expectations.

Responsibilities

• Review and assess current Clinical Operations SOPs and associated quality documents, including templates, forms, and work instructions
• Evaluate whether the existing SOP framework adequately supports combination product development and clinical execution activities
• Conduct gap assessments to identify missing, incomplete, overlapping, outdated, or inconsistent procedures and documentation
• Assess alignment with:
• 21 CFR Part 4 requirements
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