A company is looking for a Compliance and Data Privacy Officer (fractional) to lead the development and implementation of a compliance program for medical imaging real-world data.
Key ResponsibilitiesDesign and oversee a comprehensive compliance program aligned with regulatory requirements and industry standardsConduct gap analyses and update policies, procedures, and training materials to ensure compliance with relevant laws and regulationsImplement monitoring and auditing processes to ensure ongoing compliance and serve as the primary contact for regulatory agenciesRequired Qualifications10+ years of experience in compliance, regulatory affairs, or a related field within the life sciences industryAdvanced degree in Regulatory Affairs, Clinical Science, Biomedical Informatics, or a related fieldProven track record of developing and implementing successful compliance programsProfound knowledge of regulations for electronic health records and imaging data, including FDA, HIPAA, and GDPRExperience with data privacy and information security standards such as HiTrust, Fedramp, and ISO27001
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