Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
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. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.
