The Compliance Manager & Research Coordinator will serve as a critical operational and strategic partner to the Chief Compliance Officer (CCO). This dual-function role combines rigorous compliance program management with active participation in the company's clinical research and customer engagement initiatives. The ideal candidate brings hospital-based compliance or quality assurance experience, a clinical or health sciences background, and strong organizational skills with the ability to translate regulatory requirements into actionable workflows.
Key Responsibilities
I. Compliance Program Management
- Support the CCO in developing, implementing, and maintaining Octagos Health's compliance program in accordance with applicable federal and state regulations, including HIPAA, CMS, and OIG guidelines.
- Conduct scheduled and ad hoc compliance audits across operational domains including transmission interpretation, billing practices, device data handling, and staff credentialing.
- Maintain the compliance documentation repository: policies, procedures, audit logs, corrective action plans, attestations, and regulatory correspondence.
- Prepare compliance reports and status summaries for the CCO and executive leadership on a defined cadence.
- Track and manage the compliance department's KPI dashboard, including audit completion rates, open findings, corrective action timelines, and training completion metrics.
- Monitor regulatory updates (CMS, HHS, OIG work plan items) and assess impact on Octagos workflows; draft summaries for CCO review.
- Coordinate and document annual and periodic compliance training for staff.
- Assist in the preparation and response to any external regulatory inquiries, audits, or assessments.
II. Dashboard Development & Reporting
- Design and maintain compliance dashboards using available tools (Excel, Power BI, or similar platforms) to visualize KPIs, audit findings, and program health metrics.
- Build tracking systems for open compliance issues, corrective action plan (CAP) deadlines, and policy review cycles.
- Generate periodic reports summarizing compliance posture for presentation to the CCO and, as appropriate, the CEO and board.
- Collaborate with the engineering and data teams to ensure compliance metrics are accurately sourced and refreshed.
III. Research Coordination
- Support the CCO and clinical leadership in coordinating clinical research initiatives using the Octagos dataset, including IRB-exempt determinations, protocol documentation, and data use considerations.
- Assist with manuscript preparation, literature synthesis, and reference management for ongoing studies (including but not limited to arrhythmia burden analysis, inappropriate therapy reduction, and CIED monitoring outcomes research).
- Maintain an organized research documentation system: protocols, data dictionaries, study timelines, author correspondence, and submission records.
- Coordinate research activities across collaborators, including co-investigators and medical writing support, ensuring deadlines and deliverables are met.
- Support regulatory and compliance review of research-adjacent activities (e.g., press release FDA CDS review, patent filings) as directed by the CCO.
IV. Customer & Operational Support
- Respond to customer (clinic) inquiries with a compliance or regulatory dimension, in coordination with the CCO and operations team.
- Draft written communications, FAQs, and guidance documents addressing compliance-related questions from clinic partners (e.g., credentialing requirements, remote monitoring billing compliance, HIPAA data sharing).
- Support onboarding of new clinic partners by reviewing compliance documentation requirements and ensuring completeness.
- Serve as a liaison between the compliance department and clinical operations, product, and sales teams on compliance-related matters affecting customer workflows.
Qualifications
Required
- Medical degree (MD, MBBS, or equivalent) from an accredited institution - foreign-trained physicians welcome to apply.
- Minimum 2 years of healthcare compliance, quality, or regulatory affairs experience in a hospital, health system, or health technology setting.
- Demonstrated experience conducting internal audits, maintaining compliance records, and developing policies or procedures.
- Proficiency in Microsoft Office Suite, particularly Excel and Word; experience with compliance tracking tools or dashboards.
- Strong written and verbal communication skills in English; ability to produce professional-grade documentation independently.
- Highly organized, detail-oriented, and capable of managing multiple concurrent workstreams with minimal supervision.
Preferred
- Prior experience in cardiac device monitoring, remote patient monitoring (RPM), or cardiovascular practice operations.
- Familiarity with CMS billing codes related to CIED remote monitoring (CPT [redacted]9 series) and applicable reimbursement regulations.
- Experience in a clinical research coordination or research administration role.
- Knowledge of FDA regulatory frameworks for software as a medical device (SaMD) or clinical decision support (CDS) tools.
- Familiarity with IRB processes, data use agreements, and research ethics for retrospective device studies.
- CHC (Certified in Healthcare Compliance) credential or willingness to pursue certification within 12 months of hire.
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