HIPAA Compliance Manager
5 days ago
Philadelphia
Job Title: HIPAA Compliance Manager Duration: 9 months Location-: Remote (Philadelphia Preferred) otherwise East Coast based Role type -: Part time 32 Hours/week (3-4 days/week) About the Role Client is seeking an experienced Health Data & Regulatory Compliance leader to support the development, deployment, and commercialization of digital health and AI-enabled clinical solutions, including ClinicalKey AI (CKAI) and related products. This role sits at the intersection of HIPAA data governance and Software as a Medical Device (SaMD) regulatory compliance, ensuring that our products meet applicable privacy, security, and regulatory requirements throughout the product lifecycle. The successful candidate will work cross-functionally with Product, Engineering, Cybersecurity, Privacy, Legal, and Commercial teams to embed compliance into product design, architecture, and customer deployments while enabling innovation in AI-driven healthcare solutions. Key Responsibilities • HIPAA & Health Data Governance, • Lead implementation of HIPAA Privacy Rule and Security Rule requirements across products handling PHI, • Define and operationalize controls for:, • PHI collection, use, storage, and retention, • access control and minimum necessary principles, • audit logging and monitoring, • Support Business Associate Agreement (BAA) requirements and customer compliance expectations, • Partner with Privacy and Security teams on risk assessments, incident response, and remediation planning, • Regulatory Affairs - SaMD / Clinical Software, • Support regulatory strategy for products that may qualify as Software as a Medical Device (SaMD), • Provide guidance on:, • FDA pathways (e.g., 510(k), De Novo, CDS guidance), • EU MDR / IVDR considerations (as applicable), • Partner with Product and Clinical teams on:, • intended use definition, • clinical risk classification, • regulatory positioning and documentation, • AI & Clinical Software Governance, • Provide oversight for AI/LLM-enabled clinical solutions, including CKAI, • Advise on:, • appropriate use of PHI in AI workflows, • boundaries between inference vs. training data, • secondary use considerations and compliance risks, • Support development of clinical evaluation and validation frameworks, • Product & Engineering Collaboration, • Work directly with engineering teams to translate regulatory requirements into technical controls and architecture decisions, • Review system designs and data flows for compliance with:, • HIPAA, • security best practices, • regulatory expectations for clinical software, • Support implementation of secure development and deployment practices, • Risk Assessment & Compliance Oversight, • Lead or support HIPAA and regulatory risk assessments for new and existing products, • Maintain compliance documentation and evidence for:, • internal audits, • customer due diligence, • regulatory inquiries, • Identify gaps and define remediation roadmaps, • Customer & Commercial Support, • Partner with Legal and Commercial teams to:, • review BAAs and customer data protection requirements, • support RFPs and compliance questionnaires, • Provide guidance on customer-specific regulatory and data protection expectations, • Cross-Functional Education, • Educate internal teams on:, • HIPAA requirements, • PHI handling in digital products, • SaMD regulatory considerations, • Develop guidance materials and training for Product and Engineering teams Required Qualifications, • 8-10+ years of experience in healthcare compliance, regulatory affairs, or health data governance, • Deep expertise in at least one of the following areas:, • HIPAA Privacy & Security compliance, • OR SaMD / medical device regulatory affairs, • Working knowledge of the other domain, including:, • PHI handling and governance, • OR clinical software regulatory frameworks, • Experience working with:, • healthcare technology or SaaS products handling PHI, • cross-functional teams (Product, Engineering, Security, Legal), • Strong understanding of:, • cloud environments (AWS, Azure), • data security and access control principles, • Education Requirements, • Bachelor's degree in a relevant field required such as:, • Health Sciences, • Public Health, • Life Sciences, • Engineering (Biomedical, Software, or related), • Information Security / Computer Science, • Healthcare Administration, • Advanced degree preferred, such as:, • Master's degree (e.g., MPH, MS, MBA), • OR Juris Doctor (JD) with healthcare or regulatory focus, • Relevant professional certifications (preferred but not required):, • Certified in Healthcare Compliance (CHC), • Certified in Healthcare Privacy Compliance (CHPC), • Certified Information Privacy Professional (CIPP/US or CIPP/E), • HCISPP, CISSP, or equivalent (for security-focused candidates) Preferred Qualifications, • Experience with AI / machine learning systems in healthcare, • Familiarity with:, • FDA CDS / AI guidance, • EU MDR / IVDR frameworks, • Experience supporting:, • clinical decision support systems, • digital health or AI-driven healthcare products, • Certifications such as:, • CHC / CHPC, • CIPP/US, • HCISPP, • CISSP (security-focused candidates), • Key Competencies, • Ability to balance regulatory rigor with product innovation, • Strong collaboration across technical and non-technical teams, • Ability to translate complex regulatory requirements into practical, implementable solutions