Principal Regulatory Affairs Specialist
Stryker
Staff Regulatory Specialist
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Columbia City • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- 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.
Requirements
- 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.
- 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.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory intelligencecompliancesubmission pathwaysregulatory requirementsregulatory proceduresSOPsquality data evaluationpreclinical data evaluationclinical data evaluationregulatory submissions
Soft skills
project managementwritingcoordinationmentoringcross-functional collaborationanalytical skillscommunicationproblem-solvingleadershiporganizational dynamics
Certifications
Bachelor’s degree in EngineeringBachelor’s degree in Science