Eileen Sukumaran Email & Phone Number

Pleasanton , Ca, Us

Responsibilities: Evaluate international medical device regulations, including ISO 13485 and FDA 21 CFR Part 820, to develop sophisticated regulatory strategies and roadmaps that align with our organization’s compliance needs.Serve as the principal liaison between the organization and regulatory authorities, ensuring seamless coordination with internal and external stakeholders during the preparation and submission of regulatory dossiers, adhering to MDR and IVDR requirements.Formulate and implement advanced QA strategies in compliance with ISO 9001 and ISO 14971, ensuring consistent quality and regulatory adherence across all products and services.Conduct comprehensive internal audits and inspections based on GxP (Good Practice) guidelines to identify areas for improvement, ensure compliance with regulatory requirements, and prepare for external audits.Continuously create, update, and enforce data privacy policies and procedures, including GDPR and CCPA compliance, providing clear guidelines for data handling and protection practices across the organization.

New York, Ny, Us

Evoke Neuroscience creates cutting-edge technology that allows physicians to evaluate patient brain health. Evoke Neuroscience’s products enable primary care physicians to measure and track cognitive status to reduce the number of people living with treatable cognitive impairment.Key Achievements: 2020-2021 NYU EFL Cohort Graduate-May 2021Achieved company’s first 510k clearance of Class II flagship product (eVox System) Successfully increased customer retention and device re-use by 36 % within 6 months through the implementation of data-driven onboarding initiativesLaunched 300 patient clinical trial with Pacific Neuroscience Institute Achieved AFWERX SBIR Phase 1 awardLed company’s Quality Management System 13485:2016 Transition and successful FDA auditsResponsibilities: •Assist with activities associated with grant applications for other alternative funding opportunities, prepare proposals, and submit them to further the company R&D efforts.•Establish and manage data-driven approach to customer feedback, identifying improvements to product and business processes in order to meet customer expectations and enhance customer experience •Interface regularly with key internal and external partners to ensure that company’s KPIs are being achieved while meeting customer expectations •Own operations P&L and margin targets•Responsible for formalizing communication change management processes across internal verticals•Develop, implement, and maintain the Quality Management System in accordance with FDA, CMD, MDD, ISO 13485, and any other applicable regulatory standards.•Provide Quality Assurance oversight on all R&D efforts, product lines, and business processes that affect medical devices developed, manufactured, and distributed by the company.•Serve as the lead point of contact for FDA and other regulatory agencies for quality and compliance issues.•Lead risk management within project teams, ensuring risks have well defined mitigation resolutions

New York, Ny, Us

The EFL is a 9 month performance-driven program that aims to translate breakthrough science into successful business through mentorship, venture capital, and business development.

South Orange, New Jersey, Us

Nephros is a publicly traded, commercial-stage medical device company that develops and sells high-performance liquid purification filters and provides Online Hemodiafiltration (HDF) to ESRD patients.Key Achievements •Bolstered direct sales revenue 40 % within the first 6 months of working directly with sales team through strategic project planning and management•Managed sales operations program to scale and grow distribution network from local to national •Designed and implemented company’s purchasing policy in compliance with SOX and ISO 13485 Standards•Implemented succinct projections based on performance data resulting in 35% reduction in storage costs•Managed company’s project cost submission through WAWF for $3 million government contract for ONR (Office of NavalResearch)•Led gap analysis of company’s financial accounting software, conducting RFP, and identifying and implementing new accounting software•Certifying and ensuring in-house compliance with all applicable regulatory and technical audits, thereby reducing external consultant fees by 45%Responsibilities:•Serve as key liaison between CEO, R&D team, sales team, marketing, finance, manufacturer and other internal/external stakeholders to increase productivity and meet company goals•Manage and supervise domestic and international order fulfillment, supply chain, manufacturing, distribution network and production timeline•Interface with product engineers to formulate procurement planning for inventory management•Developing, streamlining and executing cost/sales bidding, negotiating customer/vendor contracts and pricing agreements•Managing sales pipeline/funnel, dashboards, KPIs and commissions within Salesforce•Conducting competitive analysis and identifying new target markets for new product development•Identified hurdles in the sales process and execute strategic solutions resulting in steady revenue growth

New York, New York, Us

Achievements:• Awarded membership to Chairman’s Departmental Appointments and Promotion Committee • Established and orchestrated Chairman’s acknowledgment day for departmental employees • Created training material and organized Chairman’s off-site retreats of Departmental Heads and Leadership team Responsibilities:• Managed cross-functional responsibilities of the surgical chairman’s office•Interfaced successfully with multi-divisions within the University system to ensure that chairman’s office adequately served the needs of the 300 physicians within the department• Managed the communication between department’s organizational management consultant with departmental staff • Managed fast paced day to day administrative calendar/OR schedule of chairman • Review and edit grant proposal and applications• Manage clinical procedure precertification