Staff Global Medical Device Compliance Engineer

Regulatory Jobs; Irvine (CA); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead regulatory compliance across the product lifecycle. You will guide standards programs and support cross-functional teams to ensure products and quality systems stay aligned with evolving global requirements.

The role emphasizes regulatory impact assessments, gap analyses, and implementing compliant actions across development, manufacturing, and quality processes. Onsite work with minimal travel is required.

Qualifications

• Bachelor's degree in Engineering or related discipline.
• 4+ years in regulatory compliance, quality, engineering, or related function.
• Experience in medical device/regulated industries.
• Experience with regulatory impact assessments and gap analyses.
• Experience with design controls, risk management, and quality systems.
• Knowledge of global medical device regulations and international standards.

Responsibilities

• Lead the Standards & Regulations Management Compliance program as the Division Process Owner.
• Monitor and identify new or revised global regulatory requirements, standards, and guidance for medical devices and quality systems.
• Interpret regulatory requirements and provide guidance to teams responsible for product development, sustaining engineering, and quality management.
• Conduct gap assessments comparing new or updated regulations to existing requirements and processes.
• Evaluate the impact of regulatory and standards changes on products and quality system processes.
• Develop and implement compliance action plans to maintain conformity across products and processes.
• Partner with cross-functional teams to execute compliance activities and ensure required documentation is completed.
• Support audits as a subject matter expert and review documentation for regulatory conformity.

Skills

Regulatory compliance

Quality engineering

Design controls

Risk management

Quality management systems

Global regs

Education

Bachelor's degree in Engineering

Job description

Stryker in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead regulatory compliance across the product lifecycle. You will guide standards programs and support cross-functional teams to ensure products and quality systems stay aligned with evolving global requirements.

The role emphasizes regulatory impact assessments, gap analyses, and implementing compliant actions across development, manufacturing, and quality processes. Onsite work with minimal travel is required.