Regulatory Affairs Specialist

Regulatory Affairs Specialist

Work Flexibility: Hybrid or Onsite

Join Stryker as a Regulatory Affairs Specialist in Bloomington, MN supporting Trauma & Extremities. This role provides hands-on exposure to sustaining regulatory activities, documentation, and global compliance across U.S. and international markets. You will support the ongoing maintenance of product registrations, evaluate changes, and contribute to regulatory systems and documentation.

What You Will Do

• Collect, organize, and maintain regulatory intelligence and documentation for local, regional, and global requirements
• Research applicable regulations, guidance, and standards to support product classification, submission strategies, and compliance activities
• Support audit readiness activities by preparing technical documentation, ensuring traceability, and maintaining data accuracy across systems
• Assist in the development, review, and maintenance of regulatory procedures and standard operating procedures
• Review change documentation to assess regulatory impact on released products and document outcomes
• Support change control activities within PLM systems, including coordinating documentation updates, routing change orders, and ensuring appropriate reviewers and approvers are assigned
• Support preparation of regulatory submissions, including dossiers, pre-submissions, and agency packages
• Support the maintenance and alignment of product and regulatory data (e.g., UDI and registration data) to ensure compliance across global markets
• Provide regulatory input for audits, inspections, and nonconformance activities, and support follow-up actions

What You Will Need

Required Qualifications

• Bachelor's degree required. Preferred in Engineering, Life Sciences, or a related field
• 0+ years of experience

Preferred Qualifications

• Master's degree in Regulatory Science or related field
• Demonstrated experience (academic, internship, or co-op) supporting regulatory documentation, submissions, or compliance activities in a regulated environment
• Exposure to U.S. FDA regulations or international medical device regulations
• Experience working with data or systems in a regulated environment preferred

US5: $76,100 - $126,900 USD Annual

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

Travel Percentage: 0%

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.