Senior Manager, Regulatory Affairs

About the Role 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, including a wide range of infection control consumables, while also supporting capital equipment. This role ensures compliance with U.S. FDA, EU MDR, and applicable global regulations throughout the product lifecycle. The leader collaborates with product development, quality, operations, marketing, clinical affairs, and global regulatory teams to integrate regulatory risk management early and continuously. What You'll Do

• Lead development and execution of comprehensive global device classifications and regulatory strategies for SWICC products, aligning regulatory requirements with business objectives and product roadmaps
• Drive U.S. submissions (e.g., 510(k), De Novo when applicable) and global filings, ensuring structured, defensible regulatory pathways for FDA Class I & II and EU MDR Class I, IIa, and IIb devices
• Integrate regulatory requirements early in concept and design phases to prevent rework and accelerate time to market
• Continuously identify and communicate regulatory risks and emerging requirements to senior leadership and develop mitigation plans
• Monitor global regulatory developments, trends, and best practices to inform strategy and business readiness
• Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls and technical documentation What We're Looking For
• Experience leading regulatory strategy and submissions for medical devices, with knowledge of FDA (510(k), De Novo) and EU MDR
• Ability to partner with cross-functional teams (development, quality, operations, marketing, clinical affairs) and guide regulatory decision-making
• Strong focus on regulatory risk management, compliance integrity, and proactive communication
• Capability to operate across global markets (U.S., EU, ROW) and influence product development roadmaps Compensation & Benefits
• Salary range: $161,920.00 - $202,400.00 annually, plus a target bonus of approximately 25%