Clinical Compliance Lead, US

Neko Health AB; New York (NY); Sur place; USD 171 000 - 209 000; Plein temps

Résumé du poste

Neko Health AB is seeking a Head of Compliance to own the clinical and healthcare regulatory compliance for the United States. You will ensure clinician licensure and credentialing, corporate structure and facility permissions, and adherence to clinical policies, consent, and documentation, while coordinating readiness for external inspections.

You will build a mature regulatory program, lead state-specific compliance, and collaborate with Regulatory Affairs and Security to gate market entry and

Qualifications

• Experience in multi-state healthcare regulatory compliance and regulatory inspections.
• Knowledge of corporate practice of medicine restrictions and professional corporation structures across multiple states.
• Ability to write clear risk assessments and residual risk statements with documentation.
• Experience leading a compliance function and coordinating with Security and Regulatory Affairs.

Responsabilités

• Own licensure, credentialing, and scope of practice processes end to end.
• Maintain regulatory readiness and inspection readiness, including evidence packs and gaps closure.
• Review clinical policies for regulatory compliance and ensure consent and documentation standards.
• Define and manage market-entry gates with clear
• Lead written boundaries with adjacent functions on device/product regulation and data protection.

Connaissances

Regulatory compliance

Healthcare regulation

Licensure & credentialing

Policy development

Regulatory reporting

Written communication

Description du poste

Mission

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.

Mission

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.

In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.

Role Purpose

The Head of Compliance is the single accountable owner of clinical and healthcare regulatory compliance for Neko Health in the United States. The postholder decides whether Neko is clear to operate a clinical service in a given state and under a given clinical scope, and holds the evidence that says so: clinician licensure and credentialing, corporate structure and facility permissions, clinical policy adherence, consent and documentation standards, and readiness for external inspection. Where a market, a service line or a clinical scope change carries a regulatory question, this role answers it and escalates the residual risk to the Senior Director, Medical Quality. Device and product regulatory obligations remain with Regulatory Affairs, and information security remains with Security; this role holds the clinical service side and works to a written boundary with both. It exists so that members receive care from a properly licensed clinician, under a compliant scope, in every market Neko enters, and so that growth into new states is gated by evidence rather than by optimism.

What You'll Deliver In The First 6–12 Months

• Develop a framework and maturity model for compliance at Neko Health using the OIG’s 7 pillars and progressing Neko’s maturity year over year.
• A written compliance position per operating state covering licensure, corporate practice of medicine and professional corporation structure, and facility or service permissions, with the residual risk named.
• A regulatory readiness assessment for the US clinical service against the applicable standards, with gaps logged, owned and dated.
• A market-entry compliance gate that any new state must pass before a clinic opens or a service line launches, agreed with the Senior Director, Medical Quality.
• Written boundaries with Regulatory Affairs and with Security, so no compliance obligation is held by two functions or by none.
• A clinical policy compliance review cycle in operation, covering consent, documentation, prescribing and scope of practice, with findings routed into the quality management system.
• A defined path for regulatory reporting and external inquiry, so any notifiable event or inspection request has a known route on the day it arrives.

How This Role Is Measured

Patient safety: contributes through clinical policy compliance, scope-of-practice control, and the completeness and timeliness of regulatory reporting on notifiable events.

Clinician competence and onboarding readiness: contributes through licensure and credential verification as a gate on a clinician being cleared to see members, and through keeping that verification current.

Perfect visit: contributes through the consent and clinical documentation standards that form part of the composite, and through compliance review of adherence to them.

Key Responsibilities

Licensure, credentialing and scope of practice

• Own the clinician licensure and credentialing process end to end, including primary source verification, renewal before expiry, and removal of clearance when a credential lapses.
• Maintain the register of permitted clinical scope by state and by clinician, and act as the decision point when a proposed activity sits at the edge of that scope.
• Advise on corporate practice of medicine restrictions and professional corporation or foreign professional corporation structures when Neko enters a new state.
• Assess and document licensure implications of telehealth delivery across state lines.

Regulatory readiness and external inspection

• Maintain a current view of the regulatory standards applicable to the US clinical service, and assess Neko against them on a stated cycle.
• Own inspection and survey readiness: evidence packs, mock inspection, and closure of identified gaps.
• Act as the named point of contact for regulatory correspondence and external inquiry relating to the clinical service, and manage the response with the Senior Director, Medical Quality.
• Define and operate the regulatory reporting route for notifiable clinical events, in step with the incident and non-conformity process.

Clinical policy and documentation compliance

• Review clinical policies for regulatory compliance before approval and maintain a review cycle so they do not fall out of date silently.
• Assess adherence to consent, clinical documentation, prescribing and record retention standards, and report findings with owners and dates.
• Route compliance findings into the quality management system as non-conformities or corrective actions rather than holding them in a parallel log.
• Contribute the compliance view to clinical scope changes, new service lines and product changes that touch the clinical pathway.

Market expansion, boundaries and team

• Operate the compliance gate for new state entry and give a clear cleared or not cleared position with the reasoning written down.
• Hold and maintain the written boundary with Regulatory Affairs on device and product regulation, and with Security on data protection and information governance.
• Build and lead the compliance function as the US service scales, including any direct reports and external counsel or consultant relationships.
• Report compliance status, risk and open gaps into the Medical Quality reporting cycle in a form the executive team can act on.

Person Specification

Essential

• At least five years in healthcare regulatory compliance, including experience in a multi-state United States provider or clinical service.
• Demonstrated experience preparing an organization for regulatory inspection, accreditation survey or state audit, and closing the resulting findings.
• Working knowledge of corporate practice of medicine restrictions and professional corporation structures across multiple states.
• Experience writing, reviewing and maintaining clinical policy in a regulated setting.
• Able to give a clear cleared or not cleared decision under commercial pressure, and to write down the reasoning and the residual risk.
• Strong written communication: this role produces documents that other functions and external parties rely on.

Desirable

• Certified in Healthcare Compliance (CHC) or equivalent professional certification.
• Advanced degree in law, health administration, public health or nursing.
• Experience of a quality management system and of the interface between clinical compliance and device regulatory obligations.
• Experience in a high-growth or health-technology environment where markets and services open faster than process matures.
• Experience of telehealth or multi-state virtual care compliance.

Compensation Range: $171K - $209K