Global Medical Device Compliance Lead

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

Job summary

Stryker Group in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead global regulatory compliance across the product lifecycle. You will provide technical leadership for standards management, assess regulatory changes, and implement actions to keep products and quality systems aligned with evolving requirements.

You will collaborate with cross-functional teams, support audits as a subject matter expert, review test protocols and reports for regulatory conformity, and guide teams

Qualifications

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

Responsibilities

• Lead the regulatory compliance program as Division Process Owner across divisions.
• Monitor global regulatory requirements and applicable standards for medical devices.
• Interpret regulations and provide guidance to product development and quality teams.
• Conduct gap assessments between new regulations and current processes.
• Evaluate impact of changes on products and QMS processes.
• Develop and implement action plans to maintain conformity.
• Support audits and review documentation for regulatory conformity.

Skills

Regulatory compliance

Quality engineering

Risk management

Design controls

Global standards knowledge

Education

Bachelor's degree in Engineering

Job description

Stryker Group in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead global regulatory compliance across the product lifecycle. You will provide technical leadership for standards management, assess regulatory changes, and implement actions to keep products and quality systems aligned with evolving requirements.

You will collaborate with cross-functional teams, support audits as a subject matter expert, review test protocols and reports for regulatory conformity, and guide teams