Product Safety & Vigilance Specialist

KARL STORZ • El Segundo, CA

4d

About The Position

We are seeking a Product Safety & Vigilance Specialist to help identify, assess, and mitigate real and potential product safety risks across our medical device portfolio. In this role, you will serve as a subject matter expert in complaint management and medical device reporting, partnering closely with global teams, regulatory authorities, and internal stakeholders to ensure compliance, continuous improvement, and patient protection.

Requirements

• 3–5 years of experience in a highly regulated environment (medical device or pharma strongly preferred)
• Hands-on experience in Product Safety, Vigilance, Quality, or Product Surveillance
• Bachelor’s degree or equivalent combination of education and experience
• Strong working knowledge of MS Office; experience with SAP/R3 preferred
• Excellent communication, collaboration, and conflict-resolution skills
• High sense of ownership, accountability, and solution-oriented mindset

Nice To Haves

• 5+ years of relevant industry experience
• Background or training as a healthcare professional or in medical/scientific disciplines

Responsibilities

• Lead investigation and assessment of potentially reportable product safety events (MDRs) and complaints
• Collect, analyze, and document product surveillance data to identify trends, risks, and opportunities for corrective action
• Review product complaints related to quality, safety, and performance; conduct interviews and device history reviews as needed
• Coordinate cross‑functional activities including failure analysis, CAPA, nonconformance, and root cause investigations
• Develop and implement proactive risk minimization and benefit–risk assessment plans
• Ensure complete, accurate, and timely documentation through investigation closure
• Support Field Safety Corrective Actions (FSCA) and multi-site product safety initiatives
• Communicate clearly and professionally with regulatory agencies and authorities
• Support FDA, ISO, and third‑party audits and follow up on corrective and preventive actions

Benefits

• Directly contribute to patient safety and regulatory excellence
• Collaborate with global experts in a cross-functional, mission-driven environment
• Grow your expertise within a complex and evolving regulatory landscape

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees