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
Strategic thinking with a risk-based approach to compliance
Why This Role Matters This role is critical to ensuring Elsevier Clinical Solutions can continue to innovate in AI-enabled healthcare technologies while maintaining the highest standards of patient data protection, regulatory compliance, and clinical integrity.
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 65.00/daily.
