Regulatory Affairs Specialist

Regulatory Affairs Specialist

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%