Regulatory Product Safety & Vigilance Specialist
Listed on 2026-01-26
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Healthcare
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Quality Assurance - QA/QC
Johnson Service Group, a nationally award-winning staffing firm, has an immediate opportunity for a Regulatory Product Safety & Vigilance Specialist with a global medical device client.
1 Year Contract | Remote in CA |
SummaryThe Product Safety & Vigilance Specialist is responsible for identifying, assessing, and managing real or potential product safety risks to ensure compliance with global regulatory requirements and internal procedures. This role serves as a subject matter expert in medical device reporting and complaint management, partnering cross-functionally to support patient safety, regulatory compliance, and continuous product improvement.
Key Responsibilities- Assess and investigate product complaints and potentially reportable events
- Perform product surveillance and trend analysis to identify safety risks
- Determine reportability, conduct risk assessments, and support regulatory reporting
- Coordinate investigations including failure analysis, nonconformance, and CAPA
- Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams
- Ensure complete, accurate, and timely documentation through case closure
- Support Field Safety Corrective Actions and regulatory audits (FDA, ISO, etc.)
- 3–5 years of experience in a regulated environment (medical device or pharma preferred)
- Experience in Product Safety, Vigilance, Quality, or Product Surveillance
- Strong documentation, analytical, and communication skills
- Proficient with MS Office; SAP experience preferred
- Bachelor’s degree or equivalent experience
JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law
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