About the role
About OpenLoop OpenLoop was co-founded by CEO, Dr. Jon Lensing, and COO, Christian Williams, with the vision to bring care anywhere. Our telehealth support solutions are thoughtfully designed to streamline and simplify go-to-market care delivery for companies offering meaningful virtual support to patients across an expansive array of specialties, in all 50 states.
About
the Role As Senior Director, Compliance and Regulatory Affairs , you will own end-to-end accountability for OpenLoop's compliance program and demonstrable regulatory readiness across every regime that governs a multi-state telehealth company. You'll report to the VP of Compliance, Healthcare, sit alongside the Director of RCM/RPM Audit as a peer, and serve as the named responsible executive in regulator-facing documentation. The Training, Education & Culture function folds directly into this role — you personally own OIG Element 3 and the broader culture-of-compliance mandate.
What You'll Do Compliance program design & oversight: Stand up and maintain all seven OIG elements as an effective, documented compliance program — you own written standards, training and education, and program oversight directly. Serve as the designated compliance officer for regulators, payors, and auditors. Policy, governance & standards: Own the policy and SOP lifecycle — authoring, versioning, attestation, and retirement across all OpenLoop subsidiaries. Maintain the governance framework and map all policies to OIG, FDA, GDPR, and CMS controls. Privacy & data protection (HIPAA/GDPR): Own the HIPAA Privacy and Security programs; manage breach response from detection through notification and documentation. Serve as or directly support the GDPR Data Protection Officer function. Investigations, ethics & screening: Oversee the hotline and investigation program — intake, triage, root-cause analysis, corrective action, and self-disclosure workflow. Own the exclusion and sanction screening program and administer the conflict-of-interest program. FDA & regulatory affairs: Establish quality-system and promotional controls for regulated device, diagnostic, and SaMD components. Track FDA regulatory status for RPM devices and connected-health components, and maintain the Stark Law and non-monetary
