Manager, Regulatory Compliance at OSI Systems | in Snoqualmie, WA

Job description

Overview At Spacelabs Healthcare, you make a difference. Every member of our worldwide team plays an integral role in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit each year from the advancements we make in patient monitoring and management, care coordination and clinical decision support. Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world. Because while we may not be at a patient’s bedside, their health is still in our hands. The Manager, Regulatory Compliance is responsible for leading Spacelabs' regulatory compliance program, including maintaining QMS alignment with current regulations and standards, audit readiness, regulatory intelligence and standards monitoring, trade compliance, and cross-functional alignment with applicable regulations and standards. The role also contributes to Spacelabs post-market surveillance programs, focused on Field Corrective Actions (FCAs), product recalls, and safety reporting to global health authorities. This highly visible people manager role oversees activities spanning regulatory intelligence and compliance, post-market surveillance, and field actions. The individual will lead and develop direct report(s), ensure compliant execution of regulatory and post-market processes, identify and address compliance gaps, and drive the safety and efficacy of Spacelabs products. The Manager, Regulatory Compliance develops and implements tools, training programs, and measurement systems to support product and process improvement. This role requires an understanding of global regulatory obligations including MDSAP nations, the EU, UK, and other global markets, as well as applicable corporate compliance and trade compliance requirements. ***Preference will be given to local candidates but consideration will be given to non-local candidates that can work remotely.*** Responsibilities Lead, develop, and mentor direct report(s); set objectives, manage performance, and build team capability to meet current and future compliance needs. Support the Quality Management System (QMS) by ensuring it remains current with applicable regulations and standards (e.g., ISO 13485, 21 CFR Part 820, MDSAP, and EU MDR); partner with the Quality department to assess changes and update procedures and work instructions as needed. Own the regulatory intelligence and standards monitoring program; track new and revised regulations, guidance, and standards across global markets, assess business impact, and coordinate implementation of required changes. Lead corporate compliance activities, including compliance policies, training, and monitoring related to anti-bribery and anti-corruption requirements, including the U.S. Foreign Corrupt Practices Act (FCPA). Support trade compliance activities, including export control classification and licensing, import and customs requirements, and restricted party screening, in accordance with applicable U.S. and international regulations. L ead and manage all Field Corrective Actions (FCAs) end-to-end, including initiation, planning, execution, health authority notification, and close-out; own Corrections and Removal (806) reporting and all global equivalent communications. Serve as the primary point of contact with global health authorities (FDA, EU Competent Authorities, Health Canada, TGA, MHRA, and others) for all field safety corrective action communications, regulatory notifications, and Field Safety Notices. Facilitate Health Haza