Senior Combination Product Quality & MDR Analyst

Johnson Johnson; Beerse; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a PQV Combination Product Analyst 4 in Beerse to manage high-volume E2E quality complaint activities and MDR assessments. You will work with internal teams and external sites to ensure accurate investigations and timely regulatory reporting.

The role requires strong leadership across QA and regulatory functions, with risk-based decision making and effective communication with management levels.

Responsabilités

• Perform high-volume end-to-end complaint handling activities including intake, triage, event review, MDR reportability, field sample recovery, priority assignment, and regulatory notification.
• Evaluate complaints to determine investigation scope and assign to appropriate sites.
• Govern daily throughput of complaints and MDR decisions to meet KPI targets.
• Conduct MDR evaluations with writtenJustification to support reportable and non-reportable regulatory decisions.
• Monitor complaints for new malfunction events for potential inclusion in MDL.
• Act as PQV point person for post-market/complaint regulatory questions and provide guidance to junior staff.
• Assess information technically to ensure accurate risk prioritization and investigations per procedures.
• Back-up PQVIS personnel to support volume fluctuations.
• Collaborate with Global Medical Safety, manufacturing sites, LOC/BQ for effective complaint handling/MDR assessments.
• Provide feedback for escalation and future product development based on product knowledge.
• Ensure timely management of complaint records and regulatory reporting per standards.
• Compile/analyze data, metrics, and trends related to complaint handling.
• Support audits/inspections and serve as SME during regulatory reviews.
• Engage with regulatory authorities and J&J councils to discuss evolving quality system trends.
• Provide workflow leadership to PQV peers for end-to-end complaint management.

Description du poste

Johnson & Johnson is seeking a PQV Combination Product Analyst 4 in Beerse to manage high-volume E2E quality complaint activities and MDR assessments. You will work with internal teams and external sites to ensure accurate investigations and timely regulatory reporting.

The role requires strong leadership across QA and regulatory functions, with risk-based decision making and effective communication with management levels.