Senior PQV & MDR Analyst (EMEA)

7566-Janssen Sciences Ireland Unlimited Company Legal Entity; Barnahely; On-site; EUR 63,000 - 101,000; Full time

Benefits offered by this job

Annual bonus

Job summary

Johnson & Johnson is seeking a PQV Combination Product Analyst IV to lead high‑volume complaint handling, MDR assessments, and regulatory reporting. You will collaborate with Global Medical Safety, manufacturing sites, and LOC/BQ to drive change management and process improvements.

Strong project leadership and regulatory knowledge are essential. The role requires 5+ years in QA/QC within regulated industries, a technical degree, and the ability to influence at all management levels.

Qualifications

• Bachelor’s or Master’s degree in technical, scientific, or engineering disciplines is preferred.
• Strong knowledge of regulatory environments and quality systems.
• Experience in leading change initiatives and project management.

Responsibilities

• Handle high-volume end-to-end complaint handling and MDR assessments.
• Lead and collaborate with multiple stakeholders to drive improvements and compliance.
• Perform data analysis to support regulatory reporting and CAPA/QI initiatives.
• Provide training and SME guidance on complaint management and regulatory reporting.

Skills

Business Alignment

Coaching

Communication

Compliance Management

Continuous Improvement

Fact-Based Decision Making

Education

Bachelor’s or Master’s degree in technical/scientific/engineering

Tools

QMS

SOP

Job description

Johnson & Johnson is seeking a PQV Combination Product Analyst IV to lead high‑volume complaint handling, MDR assessments, and regulatory reporting. You will collaborate with Global Medical Safety, manufacturing sites, and LOC/BQ to drive change management and process improvements.

Strong project leadership and regulatory knowledge are essential. The role requires 5+ years in QA/QC within regulated industries, a technical degree, and the ability to influence at all management levels.