Regulatory Compliance Specialist Role
6 days ago
Responsibilities
- Conduct regular audits of projects, processes, and clinical sites to ensure compliance with regulations and industry standards.
- Identify and address non-compliance issues, develop corrective action plans, and track progress towards resolution.
- Develop and implement procedures for managing change controls, deviations, and other quality-related activities.
Requirements
- Bachelor's degree in Life Sciences or a related field, or equivalent experience in Clinical QA or CSV QA.
- At least 4 years of related experience, or 6+ years in a regulated environment (e.g., GxP, ISO).
- Strong understanding of SDLC validation tools and testing strategies like SAST and DAST.
- Excellent communication and leadership skills, with the ability to work effectively in a fast-paced environment.
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