PQV Combination Product Analyst IV

Johnson & Johnson · Antwerp, Belgium +2 more

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Medical DeviceFull-timeCompany career page

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Role summary

Johnson & Johnson seeks a PQV Combination Product Analyst IV to manage high-volume product quality complaints and adverse events, including Medical Device Reporting assessments. The role involves end-to-end complaint handling, regulatory coordination, and process improvement across multiple manufacturing and clinical stakeholders.

What they're looking for

Medical device quality or product vigilance experience with complaint handling processes
Knowledge of MDR regulations and medical device reporting requirements
Proficiency in quality systems, risk assessment, and regulatory compliance standards
Strong cross-functional collaboration and stakeholder management skills
Technical product knowledge and data analysis capability for quality trending
Project leadership and change management experience
Regulatory communication experience with internal and external authorities

What you'll be doing

Manage high-volume complaint intake, triage, and closure activities including MDR reportability determination
Perform MDR evaluations and document regulatory justification for reportable/non-reportable decisions
Provide governance oversight of daily complaint throughput and KPI achievement
Lead cross-functional collaboration with manufacturing, clinical, and medical safety teams
Drive process improvements and change management initiatives for complaint handling workflows

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