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
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