Product Safety & Vigilance Specialist

Make an impact on patient safety.

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.

What You'll Do

• 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 crossfunctional 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 thirdparty audits and follow up on corrective and preventive actions

What You Bring

Required

• 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

Preferred

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

Why Join Us

• 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

Who we are

KARL STORZ is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and operating room integration to benefit patients and healthcare providers alike.

With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff. It's not just about the tools we create-it's about the lives we change, together.

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