Regulatory Affairs Specialist
Stryker•Bloomington, MN
•Hybrid
About The Position
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.
Requirements
- Bachelor’s degree required. Preferred in Engineering, Life Sciences, or a related field
- 0+ years of experience
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- US5 : $76,100 - $126,900 USD Annual
- Travel Percentage: 0%
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
