Product Safety & Vigilance Specialist

Every day our products and services help to save lives around the globe. Therefore, we make quality and reliability our number one priority. Get to know us and join our team. Product Safety & Vigilance Specialist Job Function: Patient Health & Regulatory Affairs Location: El Segundo, CA, US 90245; Auburn, MA, US 01501 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 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 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 Benefits Medical / Dental / Vision including a state‑of‑the‑art wellness program and pet insurance Up to 8 weeks of 100% paid company parental leave; includes maternal/paternal leave, adoption, and fostering of a child 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits) Section 125 Flexible Spending Accounts Life, STD, LTD & LTC Insurance Tuition pre‑reimbursement up to $5,250 per year Fitness reimbursement of up to $200 annually And more benefits unique to the role MA Applicants It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr KARL STORZ SE & Co. KG