Stryker
Medical Devices & Equipment
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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.
What You Need
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.
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.
United States of America Pay Ranges:
Travel Percentage: 10%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 is an EO employer – M/F/Veteran/Disability.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. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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