Related content
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits
Job description
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.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Apply Now