Global Standards & Compliance Lead – Medical Devices

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

HSA

FSAs

401(k)

ESPP

Life and AD&D

Short-term disability

Job summary

Stryker in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead global regulatory compliance across the product lifecycle. You will guide standards management and ensure medical device quality systems stay aligned with evolving requirements.

You will work with cross-functional teams to assess regulatory changes, perform gap analyses, implement corrective actions, and support internal and external audits.

Qualifications

• Bachelor's degree in Engineering, or related discipline.
• Minimum 4 years of experience in regulatory compliance, quality, engineering, or a related function.
• Experience working within the medical device, healthcare, or regulated industry.
• Experience performing regulatory impact assessments and standards gap analyses.
• Experience with design controls, risk management, and quality management 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.
• Interpret regulatory requirements and standards and provide guidance to teams responsible for product development, sustaining engineering, and quality management.
• Conduct gap assessments comparing new or updated regulations and standards 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.
• Partner with cross-functional teams to execute compliance activities and ensure documentation is completed.

Skills

Regulatory compliance

Quality engineering

Global medical device regulations

Standards interpretation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Design controls

Risk management

Quality management systems

Job description

Stryker in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead global regulatory compliance across the product lifecycle. You will guide standards management and ensure medical device quality systems stay aligned with evolving requirements.

You will work with cross-functional teams to assess regulatory changes, perform gap analyses, implement corrective actions, and support internal and external audits.