• Manage day-to-day and strategic interactions with assigned global hyperscale accounts, serving as the primary point of contact for customer relationships. • Develop and execute account plans, conduct quarterly business reviews, and track performance against defined KPIs and growth targets. • Monitor delivery schedules, open orders, and supply chain updates, coordinating internal resolution of issues to meet customer expectations. • Track and report on customer quality, pricing, and delivery KPIs, and coordinate cross-functional responses when performance gaps are identified. • Align internally with supply chain, logistics, product management, quality, and engineering teams to support and advance ongoing hyperscale programs. • Lead new product introduction activities and product transitions, managing timelines, stakeholder communication, and risk mitigation. • Own order forecasting processes and translating customer demand signals into actionable input for production and capacity planning teams. • Identify and develop new contacts, projects, and expansion opportunities within assigned hyperscale accounts to grow the scope and revenue. • Prepare and deliver tailored product and solution presentations and proposals. • Maintain regular, proactive communication with customer teams to ensure high satisfaction and strengthen the overall relationship. • Drive penetration across key customer functions including procurement, engineering, operations, sustainability, and senior leadership. • Share market intelligence and strategic insights with leadership to improve commercial and product decisions. • Coordinate with marketing on customer events, executive visits, and hyperscale-focused collateral and campaigns. • Maintain compliance with corporate procedures, ISO requirements, and documentation standards across all account activities.

• Provide effective strategic and tactical sales direction • Develop new business opportunities • Manage strategic growth plans for assigned accounts • Maintain and build strong relationships with key decision makers

Role Description The Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio. - Ensures consistent compliance with U.S. (FDA), EU MDR (2017/745), and applicable global regulations. - Collaborates with product development, quality, operations, marketing, clinical affairs, and global regulatory teams. - Serves as a primary point of regulatory accountability for cross-functional leadership engagement and health authority interactions. Qualifications - Must have FDA and Notified Body Audit Experience. - Deep technical knowledge of 21 CFR 820/QMSR, 21 CFR 807, 803, 806; EU MDR (2017/745); ISO 13485 and ISO 14971. - Strong strategic mindset with ability to align regulatory strategy with engineering, quality, and business objectives. - Excellent communication skills, influencing capability, and experience working in global, matrixed environments. - Advanced regulatory writing and documentation oversight capability. - Demonstrated ability to mentor and develop a high-performing staff. - Ability to multi-task in a fast-paced environment. - Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills. Requirements - Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline (Advanced degree preferred). - Minimum 8–10+ years of progressive regulatory experience in the medical device field. - Demonstrated experience leading FDA Class I and II submissions (e.g., 510(k)) required. - Direct engagement with FDA required; experience interacting with EU Notified Bodies required. - RAC certification or equivalent preferred. Benefits - Health, Dental, and Vision insurance benefits - 401k plan with company match - Paid Time Off - Wellness initiative & Health Assistance Resources - Life Insurance - Short and Long Term Disability Benefits - Health and Dependent Care Flexible Spending Accounts - Commuter Benefits - Parental and Caregiver Leave - Tuition Reimbursement

• The Strategic Account Manager leads company efforts to grow incremental profitable sales with customers that span multiple regions. • Establishes relationships and identifies opportunities to grow and secure business within new and existing strategic accounts. • In conjunction with the Supply Chain Services department, oversees the development and presentation of customer proposals. • Works to drive innovation. • Leads strategic opportunities for new and existing customers to generate desirable business opportunities within the assigned vertical market. • Actively works with a multifunctional team to develop a strategy to meet and exceed revenue growth targets by leveraging market intelligence, identifying opportunities within new and existing accounts, and ensuring alignment with company, regional, and branch business objectives.