Regulatory Compliance Lead, Medical Devices — Remote

OSI Systems, Inc.; Snoqualmie (WA); Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Benefits package

Bonuses and ESPP

Flexible Time Off

Job summary

OSI Systems, Inc. is seeking a Manager, Regulatory Compliance to lead global regulatory programs, ensure QMS alignment with major standards, and drive post-market surveillance and field actions.

This role oversees regulatory intelligence, training, and compliance cross-functionally to support safe, compliant products. The role requires extensive experience across FDA/EU regulations, MDR, CMDR, and global health authorities, with leadership responsibilities and collaboration across teams.

Qualifications

• Bachelor’s degree in life science or engineering; 8+ years regulatory compliance experience; 5+ years of leadership.

Responsibilities

• Lead and mentor direct report(s); set objectives and manage performance.
• Oversee QMS alignment with ISO 13485, 21 CFR Part 820, MDR and related standards.
• Own regulatory intelligence and standards monitoring; assess impact and coordinate changes.
• Lead corporate compliance programs including anti-bribery and anti-corruption (FCPA).
• Support trade compliance, including export controls and licensing; manage field actions end-to-end.

Skills

Regulatory compliance

Leadership

Risk management

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in life science or engineering

Tools

Microsoft Office

KPI/dashboard development

Regulatory intelligence tools

Job description

OSI Systems, Inc. is seeking a Manager, Regulatory Compliance to lead global regulatory programs, ensure QMS alignment with major standards, and drive post-market surveillance and field actions.

This role oversees regulatory intelligence, training, and compliance cross-functionally to support safe, compliant products. The role requires extensive experience across FDA/EU regulations, MDR, CMDR, and global health authorities, with leadership responsibilities and collaboration across teams.