Senior Manager, Regulatory Affairs

Job Overview

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 such as sterilizers, washer‑disinfectors, ultrasonic equipment, surgical lights, and operating tables.

This role ensures consistent compliance with U.S. (FDA), EU MDR (2017/745), and applicable global regulations, enabling innovation and growth while maintaining regulatory integrity throughout the product lifecycle.

This leader collaborates with product development, quality, operations, marketing, clinical affairs, and global regulatory teams to integrate regulatory risk management early and continuously in the product lifecycle. The role serves as a primary point of regulatory accountability for cross‑functional leadership engagement and health authority interactions across FDA, EU Notified Bodies, and ROW competent authorities, while partnering with regional regulatory teams to support international market requirements.

• 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, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision‑making.
• Assess regulatory impact of product and manufacturing changes (design, suppliers, processes, labeling), providing strategic guidance on change control and compliance options, ensuring U.S. regulatory compliance while aligning with international regulatory colleagues on global impact.
• Review and approve product claims, labeling, instructions for use, and commercial materials for regulatory consistency and claims support.

• Oversee development, quality control, and submission readiness for dossiers targeting the U.S., EU markets and other international technical documentation as required.
• Serve as primary interface with regulatory authorities (e.g., FDA, and Notified Bodies and other competent authorities in collaboration with regional regulatory teams) including pre‑submission interactions, submission responses, deficiency management, and post‑submission negotiations.
• Ensure regulatory documentation and systems (e.g., technical files, regulatory records) meet compliance requirements and audit expectations.

• Provide regulatory leadership for compliance and reporting obligations including U.S. corrections & removals, MDR reporting, and support EU FSCA/competent authority interactions and other global vigilance reporting activities in coordination with regional regulatory teams.
• Support inspections and audits with effective regulatory representation, ensuring rapid closure of findings and continued compliance readiness, with primary responsibility for U.S. FDA inspections and direct support for EU Notified Body audits and ROW competent authority inspections.