Staff Regulatory Specialist (Hybrid)

Staff Specialist, Regulatory Affairs

Stryker is hiring a Staff Specialist, Regulatory Affairs, (Hybrid) to join our Regulatory Affairs team in Columbia City, Indiana. This individual contributor role requires broad knowledge of regulatory frameworks, legislation, and procedures. The position demands independent judgment, attention to detail, and professional mastery gained through substantial experience in the medical device industry.

What You Will Do

• Assess regulatory intelligence to inform global and regional strategy development for trauma and extremities products.
• Evaluate regulatory environments and advise on compliance throughout the product lifecycle.
• Anticipate regulatory obstacles and develop proactive solutions for market access.
• Define submission pathways and regulatory requirements for orthopedic implants and surgical systems.
• Guide product development teams to ensure alignment with regulatory expectations.
• Lead negotiations with regulatory authorities across all stages of the product lifecycle.
• Develop and implement regulatory procedures and SOPs tailored to T&E product needs.
• Educate cross-functional stakeholders on evolving regulatory requirements relevant to trauma and extremities.
• Evaluate quality, preclinical, and clinical data to ensure submission readiness.
• Prepare and manage electronic and paper submissions for domestic and international markets.
• Monitor regulatory reviews and maintain communication with authorities.
• Support cross-functional teams during regulatory interactions, including advisory committees.
• Ensure product claims and labeling strategies meet regulatory standards for orthopedic applications.

What You Need

• Bachelor's degree in Engineering, Science, or equivalent.
• Minimum of 5 years of experience in an FDA-regulated industry, preferably medical devices.
• Minimum of 23 years of experience in Medical Device Regulatory Affairs.

Preferred

• Strong project management, writing, and coordination skills.
• Knowledge of regulatory pathways, risk-benefit analysis, and post marketing surveillance.
• Experience planning and supervising assignments with minimal oversight.
• Experience mentoring junior staff and fostering cross-functional collaboration.
• Strong analytical skills and ability to navigate organizational dynamics.

Travel Percentage: 20% 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.