Senior Director, Compliance & Regulatory Affairs

1 мес. назад

USADirectorRemote

Senior Director responsible for compliance program and regulatory readiness in a telehealth company.

О компании

We have a relatively flat organizational structure here at OpenLoop. Everyone is encouraged to bring ideas to the table and make things happen. This fits in well with our core values of Autonomy, Competence and Belonging, as we want everyone to feel empowered and supported to do their best work.
Sound like a good fit? We’d love to meet you.

Обязанности

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.
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 compensation tracking program.
Training, education & culture (OIG Element 3): Personally hold OIG Element 3 — design and maintain the compliance training curriculum across the workforce and clinician network, and set the cultural tone that compliance is infrastructure, not obstacle.
Team leadership & governance: Manage the Healthcare Investigations Manager, Policy & Governance Manager, Exclusion & Sanction Screening Lead, and HIPAA & Privacy Compliance Manager. Oversee the Conflict of Interest Program Administrator and Stark Law & Non-Monetary Comp Analyst. Prepare board and leadership reporting on program status, risk posture, and open corrective actions.
Other duties as assigned.

Требования

12+ years in healthcare compliance, regulatory affairs, or health law, with end-to-end compliance program ownership — you've run it, not just contributed to it.
Deep working knowledge of the OIG Seven Elements framework.
HIPAA Privacy and Security program ownership; GDPR experience strongly preferred.
FDA regulatory experience (device, SaMD, or digital health) a strong plus.
Experience managing and developing a compliance team in a multi-state, technology-forward healthcare or pharmacy-adjacent environment.
Familiarity with the telehealth regulatory landscape — multi-state practice authority and prescribing rules.
CHC, CHPC, CCEP, or equivalent compliance credential preferred.
Executive presence and sound judgment; comfortable being named as the responsible executive in regulator-facing documentation.
High integrity, low-ego collaborator who can influence across Legal, Product, Security, and Clinical.

Условия

In addition, for salaried positions you would also be eligible for:
Medical, Dental, and Vision plans
Flexible Spending/Health Savings Accounts
Flexible PTO
401(k) + Company Match
Life Insurance, Pet insurance, and more

Другое

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.