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Compliance Analyst, California
A company is looking for a Compliance Analyst- Non-Product Software. Key Responsibilities: Develop and execute software validation strategies and plans for computerized systems in compliance with regulatory guidelines Conduct periodic reviews, risk assessments, and maintain risk management files for software quality activities Lead collaboration with functional areas to ensure GxP compliance for non-product software applications Required Qualifications: A minimum of a Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field 4-6 years of relevant work experience in software validation and quality assurance in the healthcare or life sciences industry Strong knowledge of regulatory requirements related to software validation (e.g., 21 CFR Part 11, 210, 211, and 820) Familiarity with risk management methodologies such as ISO 14971 Proficiency in validation tools and techniques, Agile/SDLC Methodology, and documentation standards
A company is looking for a Compliance Analyst- Non-Product Software.
Key Responsibilities:
Develop and execute software validation strategies and plans for computerized systems in compliance with regulatory guidelines
Conduct periodic reviews, risk assessments, and maintain risk management files for software quality activities
Lead collaboration with functional areas to ensure GxP compliance for non-product software applications
Required Qualifications:
A minimum of a Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field
4-6 years of relevant work experience in software validation and quality assurance in the healthcare or life sciences industry
Strong knowledge of regulatory requirements related to software validation (e.g., 21 CFR Part 11, 210, 211, and 820)
Familiarity with risk management methodologies such as ISO 14971
Proficiency in validation tools and techniques, Agile/SDLC Methodology, and documentation standards
