Senior Regulatory Compliance Manager, Medical Devices

Spacelabs Healthcare; Snoqualmie (WA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Spacelabs Healthcare in the United States seeks an experienced Manager, Regulatory Compliance to lead global regulatory programs, post-market surveillance, and field actions for medical devices. This role requires leadership of a team, hands-on regulatory strategy, and cross-functional collaboration with quality, clinical, and regulatory affairs across US and international markets.

The position emphasizes audits, safety reporting, and interaction with health authorities (FDA, EU authorities,

Qualifications

• Bachelor’s degree in life science or engineering discipline or additional equivalent experience.
• 2+ years of medical device experience.
• 8+ years of regulatory compliance experience, including demonstrated focus with global regulatory authority communications.
• 5+ years of demonstrated leadership of teams.
• Knowledge of FDA (21 CFR Part 803/806/820), EU MDR, CMDR, MHRA, TGA, and related ROW regulations governing quality systems, FSCAs, adverse event reporting, and recall requirements.
• Working knowledge of corporate compliance (e.g., anti-bribery and anti-corruption, including FCPA) and trade compliance (e.g., export controls, import and customs requirements) programs.
• Experience establishing or maintaining a regulatory intelligence and standards monitoring process preferred.
• Practical knowledge of risk management principles (ISO 14971) and comfortable conducting product risk review meetings with a cross functional team.
• Proficiency in data analysis, trending tools, and KPI/dashboard development; professional knowledge of statistical methods preferred.
• 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 desired.
• Working knowledge of agentic AI and ability to leverage AI to support work obligations preferred.
• May be required to support business operations across multiple time zones, including participation in early morning, evening, or overnight meetings to meet business requirements.
• Less than 5% travel may be required.
• Ability to work in the U.S. without visa sponsorship now or in the future.

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.
• 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, including notified body and MDSAP audits, representing regulatory compliance, FCA, and post-market surveillance activities.
• 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.
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the company’s values, Code of Ethics and Conduct, and applicable compliance policies.
• Duties may be modified or assigned at any time to meet the needs of the business.

Skills

Regulatory compliance

Leadership

Data analysis

KPI/dashboard development

Communication

Microsoft Office

Project management

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor’s degree in life science or engineering

Tools

Microsoft Office

Job description

Spacelabs Healthcare in the United States seeks an experienced Manager, Regulatory Compliance to lead global regulatory programs, post-market surveillance, and field actions for medical devices. This role requires leadership of a team, hands-on regulatory strategy, and cross-functional collaboration with quality, clinical, and regulatory affairs across US and international markets.

The position emphasizes audits, safety reporting, and interaction with health authorities (FDA, EU authorities,