Product Analyst

• Handle high-volume end-to-end product quality complaint activities and adverse events
• Perform Medical Device Reporting (MDR) assessments and document reportable/non-reportable regulatory decisions
• Intake, triage, review, investigate, prioritize, and close complaints
• Determine MDR reportability, recover field samples, conduct due diligence, perform trend analysis, defect coding, risk criticality assessment, and ensure holistic investigations
• Evaluate QTL and ULC exceedances, determine investigation requirements, and assign investigations to applicable sites
• Provide governance and oversight of complaint throughput, prioritization, MDR decisions, and KPI performance
• Monitor complaints for new malfunction events requiring inclusion in malfunction description lists
• Serve as PQV point person for post-market and complaint-handling regulatory/MDR questions
• Provide guidance to subordinate Analyst roles and other PQV functions
• Assess technical information, risks, investigations, and MDRs according to procedures, standards, and regulations
• Provide backup PQVIS investigation support during increased complaint volumes
• Collaborate with Global Medical Safety, manufacturing sites, LOC/BQ, and cross-functional stakeholders
• Provide technical and product feedback for issue escalation, product enhancements, and future development
• Ensure timely and uniform complaint records and regulatory reporting
• Compile and analyze complaint-handling data, metrics, and trends
• Support internal and external audits and inspections as a subject-matter expert
• Interact with regulatory authorities, J&J operating companies, and global councils on quality-system regulatory trends
• Provide product workflow leadership to PQV peers
• Oversee PQC complaint monitoring and analyze monitoring outcomes
• Lead root-cause identification and corrective-action coordination for compliance risk events, including CAPA/QI documentation
• Lead process mapping and changes for SOPs, job aids, and work instructions
• Drive process improvements using Process Excellence tools and lead or participate in special projects
• Execute statistical and data-driven processes for controlled risk management and decision-making
• Lead remediation activities and prepare protocols, results documentation, and report approvals
• Develop and deliver training on processes, complaint handling, and regulatory reporting
• Facilitate and collaborate with PQV Reporting and Surveillance on New Product Introduction processes
• Interact with IT partners and application vendors as required

Product Analyst jobs in Switzerland

PQV Combination Product Analyst IV