Eko Health

Compliance

• This role drives Eko's ability to bring AI-powered cardiac and pulmonary detection tools to market globally by leading regulatory strategy across the full product lifecycle.
• The Director owns the overall regulatory strategy for the company and drives highly coordinated submissions and approvals (FDA, CE Mark, Health Canada, PMDA, etc.) for our SaMD and hardware portfolio, ensuring accelerated market access while maintaining compliance with evolving requirements like EU MDR and emerging AI regulations.
• By embedding regulatory intelligence early in product development, this leader enables innovation, mitigates business risk, and unlocks revenue growth across priority geographies transforming novel detection tools into cleared, commercially viable products that improve patient outcomes.
• Proven ability to own and drive end-to-end regulatory strategy from concept through commercialization, including portfolio prioritization and resource allocation aligned with business goals.
• Lead and execute regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA) for medical device hardware and SaMD products, directly authoring technical documentation and managing agency interactions (e.g., interactive responses and presubmission meetings) to secure timely approvals.
• Serve as the regulatory lead for the company, managing all interactions with regulatory authorities including pre-submissions, responses to deficiencies, inspections, and ongoing correspondence.
• Partner with cross-functional teams (R&D, Clinical, Quality, Product, Commercial) to define and proactively embed regulatory requirements into product development workflows and align global market access strategies with business priorities.
• Collaborate with Head of Quality to ensure the Quality Management System represents state-of-the-art practices and supports regulatory compliance and post-market surveillance programs.
• Establish and lead a proactive regulatory intelligence program to monitor evolving global requirements (EU MDR, EU AI Act, FDA SaMD guidance, IMDRF standards), provide and implement strategic recommendations to executive leadership on product roadmap, risk mitigation, and competitive positioning.
• Build and mentor a high-performing regulatory team while driving the continuous optimization of internal workflows and submission processes, establishing scalable processes that support rapid portfolio expansion while maintaining compliance excellence.
• Ensure compliance with company policies and applicable laws across all regulatory activities, including adverse event reporting, clinical studies and evaluations, and labeling requirements.

Director, Global Regulatory Affairs – Intelligence

Account Manager

• Own renewal, retention, and expansion outcomes across a defined portfolio of strategic Telehealth accounts.
• Build trusted relationships with executive, clinical, operational, technical, and procurement stakeholders within hospitals, health systems, and enterprise healthcare customers.
• Develop a deep understanding of each customer’s goals, workflows, use cases, and definition of success.
• Create and manage account plans that support adoption, utilization, customer satisfaction, renewal, and expansion.
• Identify, scope, and drive expansion opportunities within existing health system logos, including new sites, service lines, use cases, licenses, devices, integrations, and product adoption.
• Lead commercial discussions related to renewals, scope growth, pricing changes, and contract expansion.
• Partner with the Director of Sales - Telehealth, Sales Operations, and Commercial leadership to forecast renewals, expansion pipeline, account health, and revenue risk.
• Support cross-sell opportunities within existing accounts, including potential collaboration with the SENSORA Enterprise team where appropriate.
• Facilitate customer onboarding, training, implementation support, performance measurement, renewal, and expansion in partnership with internal teams.
• Deliver customer reports, business reviews, and value summaries that demonstrate Eko’s impact, including utilization, workflow adoption, customer outcomes, and ROI where applicable.
• Synthesize customer feedback and partner with Product, QA, Engineering, Implementation, and Commercial teams to continually improve the customer experience and platform.
• Maintain accurate account plans, customer activity, pipeline updates, renewal status, and forecasts within CRM systems.
• Ensure compliance with company policies and applicable laws and regulations.
• Other duties as assigned.

Enterprise Account Manager, Telehealth

Account Executive

• Own new business generation and quota attainment for Eko’s Telehealth platform across assigned enterprise healthcare segments.
• Build and execute a target account strategy focused on hospitals, health systems, IDNs, virtual care programs, telehealth departments, and distributed care organizations.
• Prospect into new accounts through a multi-channel approach, including outbound email, phone, LinkedIn, referrals, events, partner channels, and account research.
• Identify and engage key decision makers and influencers, including leaders in virtual care, telehealth, IT, clinical operations, innovation, nursing, specialty care, and executive leadership.
• Create and qualify new sales opportunities by understanding customer workflows, current virtual care infrastructure, unmet needs, budget, timeline, stakeholders, and decision process.
• Develop and maintain a strong pipeline of qualified opportunities sufficient to achieve quarterly and annual new business targets.
• Lead commercial conversations, pricing discussions, proposal development, negotiation, and contract execution in partnership with Sales leadership and internal stakeholders.
• Partner with Solutions Engineering, Product, Customer Success, and Implementation teams to address technical, workflow, security, and integration questions during the sales process.
• Collaborate with Marketing to refine sales messaging, prospecting templates, pitch decks, sell sheets, case studies, and other materials supporting the Telehealth sales motion.
• Maintain accurate Salesforce records, including account plans, contacts, activity history, opportunity stages, next steps, close dates, forecasts, and pipeline health.
• Respond to inbound leads quickly and professionally, ensuring timely qualification and follow-up.
• Ensure compliance with company policies and applicable laws and regulations.
• Other duties as assigned.

Enterprise Account Executive, Telehealth

Sales

• Own new business generation and enterprise revenue for SENSORA across large hospitals and integrated delivery networks, from prospecting through contract execution.
• Personally lead and close complex, multi-stakeholder enterprise sales cycles, including 6- and 7-figure opportunities.
• Develop and execute territory and account strategies across key enterprise segments, including health systems, physician groups, and value-based care networks.
• Build, mentor, and manage a small initial team of enterprise sellers as needed, expanding the team over time as the business scales.
• Establish trusted, multi-threaded relationships with senior clinical, IT, finance, and executive stakeholders within health systems.
• Develop and present ROI-driven business cases that align SENSORA’s clinical and operational value with health system priorities.
• Partner cross-functionally with Product, Clinical, Marketing, Implementation, and Customer Success teams to support pilots, evaluations, and enterprise rollouts.
• Maintain accurate forecasting, pipeline management, and account data within CRM systems.
• Navigate enterprise procurement processes, including legal, privacy, security, value analysis, and clinical governance reviews.
• Act as a voice of the customer, providing input into go-to-market strategy, product roadmap, pricing, and enterprise messaging.
• Ensure compliance with company policies and applicable laws and regulations.
• Other duties as assigned.