Regulatory Compliance Lead

Job Description Human, a subsidiary of Digital Factory is seeking a knowledgeable and proactive Regulatory Compliance Lead to guide the company's healthcare regulatory compliance strategy and help ensure its technology, business operations, and partnerships align with applicable legal, regulatory, privacy, and security requirements. This individual will work closely with executive leadership, product development, engineering, healthcare partners, and business development teams to identify regulatory risks, establish compliance policies, and incorporate regulatory considerations into product development and commercialization. The ideal candidate brings a strong understanding of healthcare regulations, patient privacy, data governance, and digital health technology. This role is particularly suited to someone who can translate complex regulatory requirements into practical business processes while supporting innovation and responsible growth in an evolving healthcare technology environment. This is an equity-only, fractional opportunity. There is no salary or hourly compensation at this time. Department: Human (a Digital Factory healthcare company) Reports to: C-Suite, Location: Chicago, Illinois Who We Are Our team's digital inventiveness and mobile location expertise creates brand stories that produce results. We are seasoned professionals who have worked in marketing, technology, mobile, and beyond. Our skills include Micro-fencing, mobile strategy, data analytics, and more. Key Responsibilities THIS POSITION WILL ENTAIL: Develop, implement, and maintain a regulatory compliance framework aligned with applicable federal and state healthcare laws and regulations.Monitor regulatory developments affecting digital health technology, healthcare data analytics, patient engagement, and location-based services.Assess regulatory requirements associated with the company's products, services, business model, and healthcare partnerships.Establish policies, procedures, and internal controls to support ongoing compliance.Identify regulatory risks and recommend practical strategies to mitigate potential legal, operational, and reputational exposure.Coordinate with external legal counsel and subject-matter experts when specialized regulatory interpretation is required.Guide privacy and data governance practices involving protected health information (PHI), personal information, and sensitive location data, as applicable.Evaluate applicable requirements under HIPAA and the HITECH Act, state privacy laws, and other relevant data protection regulations.Support the development and maintenance of privacy policies, data handling procedures, consent practices, and data retention requirements.Review data collection, access, sharing, storage, and disclosure practices to identify privacy and compliance risks.Collaborate with engineering and product teams to incorporate privacy-by-design and security-by-design principles.Help establish appropriate processes for responding to privacy incidents, suspected data breaches, and regulatory inquiries.Evaluate third-party vendors and technology partners for relevant privacy and compliance risks.Partner with product management, software engineering, and data teams to assess regulatory considerations throughout the product development lifecycle.Review proposed product features, data analytics capabilities, location-based notifications, and patient engagement workflows for potential compliance implications.Help determine whether specific products, functionality, intended uses, or marketing claims may trigger additional regulatory obligations, including potential FDA oversight.Support documentation of compliance requirements, product risk assessments, and mitigation plans.Evaluate the regulatory implications of healthcare data integrations, interoperability initiatives, and third-party technology services.Help establish compliance checkpoints for product releases, significant feature changes, and new market expansion.Review healthcare partnership models, commercial agreements, and data-sharing arrangements for relevant compliance considerations.Support the evaluation of business associate relationships, Business Associate Agreements (BAAs), data processing agreements, and other contractual safeguards, as applicable.Partner with business development and leadership to assess regulatory requirements associated with hospitals, health systems, health plans, providers, and other healthcare organizations.Help ensure that marketing materials, product descriptions, and commercial representations appropriately reflect the company's capabilities and regulatory obligations.Support compliance due diligence during partnership development, vendor onboarding, and commercialization initiatives.Establish and maintain a practical compliance program appropriate to the company's size, stage of development, and risk profile.Develop compliance policies, standard operating procedures, risk registers, and internal documentation.Conduct periodic compliance assessments and coordinate remediation of identified gaps.Establish employee and contractor training on relevant privacy, security, regulatory, and ethical obligations.Maintain documentation demonstrating compliance activities, decisions, risk assessments, and corrective actions.Develop reporting mechanisms to communicate compliance status, emerging risks, and recommended actions to executive leadershipPrepare the organization for customer due diligence, healthcare partner assessments, regulatory inquiries, and applicable audits.Track regulatory changes and translate them into actionable recommendations for leadership and operational teams.Coordinate internal reviews of compliance controls and follow through on corrective action plans.Assess emerging risks related to artificial intelligence, healthcare analytics, sensitive data, and evolving digital health regulations when applicable.Help establish scalable compliance processes that support future growth, new partnerships, and entry into additional markets. Desired Skills Qualifications What You Bring: Bachelor’s degree in healthcare administration, Health Informatics, Public Health, or a related field.Professional certifications such as CHC, CHPC, CHPS, or CIPP/US are desirable but not required.5+ years of experience in healthcare regulatory compliance, privacy, risk management, healthcare technology compliance, or related discipline.Demonstrated knowledge of HIPAA Privacy and Security requirements and the HITECH Act.Experience interpreting healthcare regulations and translating requirements into policies, procedures, and operational controls.Understanding of healthcare data privacy, data governance, vendor risk, and contractual compliance considerations.Experience conducting compliance assessments, identifying risks, and coordinating corrective actions.Strong analytical, organizational, documentation, and problem-solving skills.Ability to communicate regulatory requirements clearly to technical and nontechnical stakeholders.Ability to work independently and collaborate effectively across a distributed, cross-functional team.Experience supporting digital health, healthcare SaaS, patient engagement platforms, health data analytics, or healthcare interoperability.Familiarity with state consumer privacy laws and requirements governing sensitive health and location data.Experience with healthcare data-sharing arrangements, BAAs, vendor agreements, and privacy impact assessments.Knowledge of relevant FDA requirements for digital health products, where applicable.Familiarity with HITECH, applicable FTC requirements, and recognized security and privacy frameworks.Experience supporting healthcare organizations, health plans, hospitals, health systems, or healthcare technology vendors. What You Get An equity-based opportunity to help build and scale Human, the healthcare subsidiary of Digital Factory.A collaborative, inclusive culture that values innovation, clarity, purpose, and measurable impact. Compensation This is an equity-only, fractional opportunity. There is no salary or hourly compensation at this time. At Digital Factory, we’re committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Digital Factory believes that diversity and inclusion among our teammates is critical to our success, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. Digital Factory is an Equal Opportunity Employer