Senior Specialist responsible for corrective actions in Global Trade Compliance at L3Harris. Track compliance incidents and facilitate corrective action processes across US and non - US jurisdictions.
About the role
- Staff Specialist in Regulatory Affairs at Stryker, focusing on medical devices and regulatory compliance. Responsibilities include assessments, submissions, and stakeholder education in a hybrid setting.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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