Compliance and Data Privacy Officer

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Segmed, Inc.

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Medical Imaging • Radiology • Medical AI • Adjudication • Medical Experts

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Description

• Segmed is revolutionizing healthcare research through a medical imaging data platform. • The role leads the development of a compliance program for medical imaging data. • Ensures Segmed adheres to standards of regulatory compliance and data privacy. • The role requires innovation and scientific expertise in compliance practices.

Requirements

• Proven track record of developing and implementing successful compliance programs. • 10+ years of experience in compliance, regulatory affairs, or a related field within the life sciences industry. • Advanced degree in Regulatory Affairs, Clinical Science, Biomedical Informatics, or a related field. • Solid understanding of healthcare and life sciences ecosystems for medical devices. • Profound knowledge of the regulations and standards for electronic health records, electronic record systems, and real-world imaging data, including FDA, HIPAA, GDPR, and other data protection laws. • Familiarity with imaging technologies and data. • Experience implementing and maintaining data privacy and information security standards such as HiTrust, Fedramp, SOC2, ISO27001 • Experience with the validation, testing, and compliance life cycle of artificial intelligence (AI) algorithms, including knowledge of regulatory requirements and best practices for ensuring the ethical and effective use of AI in healthcare and life sciences. • Awareness of privacy-preserving methodologies, including tokenization and synthetic data. • Familiarity with hyperscale cloud providers (MS,Google,AWS, etc…) and their configuration to ensure compliance and safety across the enterprise. • Familiarity with security first principles in SDLC, including appropriate processes and tools/configurations in support of a zero-trust architecture. • Proficiency with security documentation for electronic systems, organizational infrastructure, and data. • Exceptional attention to detail. • Strong problem-solving skills, with the ability to conduct thorough gap analyses and risk assessments. • Excellent communication and interpersonal skills, with the ability to effectively train and educate diverse audiences. • Enjoys working independently and as part of a cross-functional team. • High ethical standards and a commitment to fostering a culture of compliance and integrity.