Senior PQV Quality & MDR Analyst - Product Complaints

Johnson & Johnson Co.; Ringaskiddy; On-site; EUR 63,000 - 101,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in the EMEA region is seeking a PQV Combination Product Analyst IV to manage high-volume end-to-end complaint handling and MDR assessments. You will coordinate with multiple partners to deliver timely investigations, documentation and regulatory decisions.

The role requires strong QA knowledge, project leadership, and the ability to drive change across global teams while ensuring compliance and effective communication with management and stakeholders.

Qualifications

• Bachelor’s or Master’s degree in technical, scientific, or engineering disciplines preferred.
• Biomedical Engineer, Registered Nurse, or similar healthcare background preferred.
• Location: EMEA with travel up to 5–10% internationally.

Responsibilities

• Handle high-volume end-to-end complaint handling and MDR assessments.
• Provide guidance to PQV peers and ensure accurate regulatory documentation.
• Collaborate with Global Medical Safety, manufacturing sites and LOCs.
• Lead risk assessment and change management across functional regions.

Skills

Quality Assurance

Regulatory Knowledge

Project Management

Communication

Problem Solving

Process Improvement

Stakeholder Engagement

Education

Bachelor's or Master's in technical/scientific/engineering

Biomedical Engineer / Nurse / Physician Assistant background preferred

Job description

Johnson & Johnson in the EMEA region is seeking a PQV Combination Product Analyst IV to manage high-volume end-to-end complaint handling and MDR assessments. You will coordinate with multiple partners to deliver timely investigations, documentation and regulatory decisions.

The role requires strong QA knowledge, project leadership, and the ability to drive change across global teams while ensuring compliance and effective communication with management and stakeholders.