Work Flexibility: Hybrid Join Stryker's Ortho Tech Division as a Regulatory Affairs Specialist and support regulatory activities for products used across a broad portfolio of Orthopedic Instruments. In this role, you will help maintain regulatory compliance, support submission activities, and provide regulatory intelligence that enables products to meet global market requirements. This is an excellent opportunity for an early-career professional to develop foundational regulatory affairs expertise while partnering with cross-functional teams in a highly regulated environment. What You Will Do Monitor regulatory requirements, guidance documents, and industry standards across applicable global markets. Research and compile regulatory requirements, approval pathways, and compliance information for products and programs. Collect, organize, and maintain regulatory intelligence files, submission documentation, and supporting records. Assist in preparing regulatory dossiers, pre-submission packages, and submission materials for regulatory agencies. Track regulatory submissions and applications under review and provide status updates to stakeholders. Maintain records of communications, commitments, and outcomes with regulatory authorities and other stakeholders. Coordinate meeting logistics and develop supporting materials for discussions with regulatory agencies and internal teams. Organize and support the review of preclinical, clinical, quality, and technical documentation used to meet regulatory requirements. What You Will Need Required
Qualifications
Bachelor’s degree required. Preferred to be in Engineering, Science, Regulatory Science, or a related technical field with 3-7 years of work experience. Demonstrated ability to work with technical, scientific, or regulated documentation through academic, internship, co-op, or professional experience.
Preferred Qualifications
Master’s degree in Regulatory Science or a related field.
Experience
supporting regulatory affairs, quality, clinical, research, or compliance activities in a regulated industry. Familiarity with medical device, pharmaceutical, biotechnology, or other regulated industry regulations and standards. Travel Percentage: 10% 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.