Regulatory Affairs Specialist - Trauma & Extremities

4w4 weeks ago

Stryker

Bloomington, US · Full-time · $76,100 – $126,900

About this role

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. Day-to-day tasks include collecting regulatory intelligence, researching applicable regulations, and preparing technical documentation for audit readiness.

You will collaborate with cross-functional teams to review change documentation, assess regulatory impact on released products, and support change control activities within PLM systems. This environment emphasizes accuracy, traceability, and alignment with global regulatory requirements.

This role offers the opportunity to build expertise in medical device regulations and contribute to submissions, UDI maintenance, and audit support. It is ideal for early-career professionals looking to grow within a leading medical technology company.

Requirements

Bachelor’s degree required, preferred in Engineering, Life Sciences, or a related field
0+ years of experience
Master’s degree in Regulatory Science or related field preferred
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
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