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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 2–3 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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.