Senior Staff Regulatory Affairs/Quality Compliance Specialist, Pharmaceuticals

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $110.1k - $183.4k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Stryker

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1941

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Stryker is a global leader in medical technology, providing innovative products and services across the healthcare sector. With a presence in countries across the Americas, Asia Pacific, Europe, and the Middle East & Africa, Stryker offers a wide range of medical technologies, including orthopedic implants, surgical equipment, and advanced hospital devices. The company is committed to improving patient outcomes and healthcare efficiency. Stryker continues to expand its global reach, offering localized solutions to meet diverse healthcare needs worldwide.

📋 Description

• Develop and execute global regulatory strategies for 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) • Ensure 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 CAPA activities, including investigation, implementation, effectiveness verification, and documentation • Author, review, and approve quality system procedures, work instructions, forms, and quality plans • Deliver QMS training across the organization • Collaborate with regulatory agencies and cross-functional teams on submissions, regulatory inquiries, manufacturing changes, and compliance activities

🎯 Requirements

• 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 • Preferred Lead Auditor certification • Preferred experience working within Good Manufacturing Practice (GMP) environments • Preferred experience with pharmaceutical quality management systems, audits, CAPA management, and regulatory inspections

🏖️ Benefits

• Remote work arrangement • 10% travel opportunity/requirement • Annual salary compensation