• 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.

• Create, drive, and execute on revenue upsell opportunities within a specified book of business • Partner with Renewals Managers to scope renewals for growth and execute a timely and strategic renewals process within your book of business • Own the responsibility of all commercial activity within your given book of business • Generate business opportunities through SDR partnerships, CSM Partnerships, RM Partnerships, professional networking, client account blue printing, customer MQLs, etc. • Drive brand awareness, TSO campaigns, and lead generation • Meet and exceed all monthly, quarterly, and annual sales quotas from the first quarter in seat • Own the sales cycle - from lead generation to closure • Collaborate with the Customer Success Team to gain deep understanding of client adoption and engagement • Develop and deliver on a territory business plan working closely with sales leadership and internal partners • Maintain account and pipeline opportunity forecasting within Salesforce.com • Proactively manage a book of business and own meeting/exceeding upsell goals