Stryker Corporation

Senior Staff Regulatory Affairs/Quality Compliance Specialist, Pharmaceuticals (Remote)

Stryker Corporation$110K — $238K *
US-AnywhereRemote in Lansing, MI
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree required
  • 6+ years in FDA or Health Canada regulated industry
  • 6+ years in regulatory affairs or quality compliance
  • Experience with regulatory submissions for clinical studies or product approvals
  • Familiarity with Good Manufacturing Practices (GMP) preferred

Responsibilities

  • Develop and execute global regulatory strategies for clinical and post-approval submissions
  • Prepare and submit regulatory documentation including marketing and clinical trial applications
  • Maintain and enhance the Pharmaceutical Quality Management System for compliance and efficiency
  • Lead audits and monitor corrective actions to ensure audit program effectiveness
  • Analyze quality system metrics and prepare reviews for management
  • Lead CAPA activities, driving investigations and documentation for process improvement
  • Author and approve quality system documentation while training staff on QMS procedures

Benefits

  • Remote work flexibility
  • Opportunity for leadership in regulatory affairs
  • Collaboration across diverse functions and teams
  • Potential for professional advancement in a reputable company
  • Support for continuous improvement initiatives within the organization
Full Job Description
Work Flexibility: Remote

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:
  • 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
View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ

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