[Hiring] Senior Staff Regulatory Affairs/Quality Compliance Specialist @Stryker

Role Description

Stryker is seeking a Senior Staff Regulatory Affairs/Quality Compliance Specialist to join our Endoscopy division. This is a remote position located anywhere within the United States.

As the Senior Staff Regulatory Affairs/Quality Compliance Specialist, you will provide leadership for global regulatory submissions, quality management system oversight, audit readiness, and compliance initiatives supporting pharmaceutical products and clinical investigations. Working across development, manufacturing, quality, and regulatory functions, you will help ensure products and processes meet applicable regulatory and quality requirements throughout their lifecycle.

What You Will Do

• Develop and execute global regulatory strategies to support clinical investigations, product registrations, and post-approval changes for pharmaceutical products.
• Prepare, review, and submit regulatory documentation, including clinical trial applications, marketing applications, manufacturing dossiers, and post-approval submissions.
• Maintain and continuously improve the Pharmaceutical Quality Management System (QMS), ensuring compliance, efficiency, and inspection readiness.
• Lead internal and supplier audits, document findings, monitor corrective actions, and support audit program effectiveness.
• Analyze quality system metrics and trends, prepare Annual Product Quality Reviews, and present findings to management.
• Lead nonconformance and corrective and preventive action (CAPA) activities, including investigation, implementation, effectiveness verification, and documentation.
• Author, review, and approve quality system procedures, work instructions, forms, and quality plans while delivering QMS training across the organization.
• Collaborate with regulatory agencies and cross-functional teams to support submissions, regulatory inquiries, manufacturing changes, and compliance activities.

Qualifications

• Required: Bachelor’s degree
• 6+ years of experience in a pharmaceutical, biotechnology, or other FDA and/or Health Canada regulated industry.
• 6+ years of experience in pharmaceutical regulatory affairs, quality systems, or quality compliance.
• Experience preparing regulatory submissions and supporting product approvals, clinical study applications, or post-approval regulatory activities.

Requirements

• Preferred: Certificate in Regulatory Affairs.
• Lead Auditor certification.
• Experience working within Good Manufacturing Practice (GMP) environments.
• Experience with pharmaceutical quality management systems, audits, CAPA management, and regulatory inspections.

Benefits

• United States of America Pay Ranges:
• USN: $110,100 - $183,400 USD Annual
• US5: $115,600 - $192,600 USD Annual
• US10: $121,100 - $201,700 USD Annual
• US15: $126,600 - $210,900 USD Annual
• US20: $132,100 - $220,100 USD Annual
• US30: $143,100 - $238,400 USD Annual
• Travel Percentage: 10%

Company Description

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.