Regulatory Compliance Manager

Overview

At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.

The Regulatory Compliance Manager is responsible for leading Spacelabs post‑market surveillance programs — focused on Field Corrective Actions (FCAs), product recalls, and safety reporting to global health authorities — while serving as a key contributor to the organization's broader regulatory compliance framework, including QMS compliance, audit readiness, regulatory intelligence, and cross‑functional alignment with applicable regulations and standards.

This highly visible role oversees activities spanning post‑market surveillance, field safety, and regulatory compliance. The individual will ensure compliant execution of post‑market processes, identify and address compliance gaps, and drive the safety and efficacy of Spacelabs products. The Regulatory Compliance Lead develops and implements tools, training programs, and measurement systems to support product and process improvement.

This role requires thorough understanding of global regulatory obligations including MDSAP nations, EU, UK, and other global markets.

Location

This is a hybrid position based in Snoqualmie, Washington, with the expectation of onsite collaboration 3 or more days per week, depending on business needs.

Responsibilities

• Lead 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 Hazard Evaluations (HHEs) to drive risk‑based decision making on product safety issues; ensure timely escalation of defects, safety conditions, and use‑related issues affecting product performance.
• Support the Quality department with adverse event and vigilance reporting, including MDRs and global equivalents; ensure accurate and timely submission in accordance with local regulations.
• Partner with clinical and regulatory personnel to prepare, maintain, and submit Post Market Surveillance plans and reports; ensure regulatory records demonstrate ongoing compliance with ISO 13485, MDR (EU) 2017/745, and other applicable standards/regulations.
• Monitor and report product safety performance metrics (KPIs); identify trends, drive corrective improvements, and report findings to management with quantified objectives.
• Support regulatory audits and inspections representing FCA and post‑market surveillance activities, procedures, and records.
• Serve as a regulatory compliance resource to peers and cross‑functional teams; provide guidance on applicable medical device regulations, standards, and quality requirements to support informed decision‑making across the business.
• Support the Quality Management System (QMS) by contributing to the development, maintenance, and continuous improvement of procedures and work instructions in compliance with applicable regulations and standards.
• Participate in maintaining the internal audit program, ensuring consistency of audit templates/checklists with current applicable regulations.
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

Qualifications

• Bachelor’s degree in life science or engineering discipline or additional equivalent experience.
• 8+ years of medical device experience required.
• Experience with US FDA Class II devices (minimally, including active devices and SaMD).
• 4+ years of post‑market surveillance experience with demonstrated focus on field corrective actions, recalls, and global health authority communications required.
• 3+ years of demonstrated leadership of teams, colleagues, and/or programs.
• In‑depth knowledge of FDA (21 CFR Part 803/806/820), EU MDR, CMDR, MHRA, TGA, and related ROW regulations governing FSCAs, adverse event reporting, and recall requirements.
• Strong practical knowledge of risk management principles (ISO 14971) and comfortable conducting Health Hazard Evaluations with a cross‑functional team.
• Proficiency in data analysis, trending tools, and KPI/dashboard development; professional knowledge of statistical methods.
• Strong technical written and verbal communication skills; ability to work effectively across all levels of a global organization and remain composed in urgent circumstances.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Project management experience is highly desired.
• Working knowledge of agentic AI and ability to leverage AI to support work obligations preferred.
• Less than 5% travel may be required.

Benefits

Please review our benefits here: Life at OSI.

Equal Opportunity & EEO

Equal Opportunity Employer – Disability and Veteran.

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