Senior PQV Analyst IV: Product Quality & MDR

Biopharma Careers; Schaffhausen; Hybrid; CHF 120,000 - 170,000; Full time

Job summary

Johnson & Johnson is seeking a PQV Combination Product Analyst IV to manage high-volume E2E complaint handling and MDR assessments. The role collaborates with Global Medical Safety, LOCs, and manufacturing sites to ensure compliant investigations and regulatory reporting, while guiding junior PQV staff and coordinating with external partners.

Requirements include a Bachelor’s or Master’s in a technical/scientific field and strong regulatory knowledge, with up to 5-10% travel across regions.

Qualifications

• Bachelor’s or Master’s degree in technical, scientific, or engineering disciplines required (preferred).
• Experience in pharmaceutical and/or Medical Device or other highly regulated industry.
• Strong organization, prioritization and communication skills.

Responsibilities

• Lead high-volume end-to-end complaint handling and MDR assessments.
• Collaborate with Global Medical Safety, LOCs, manufacturing sites and QA to deliver compliant investigations.
• Support internal and external audits/inspections and act as SME during regulatory reviews.
• Develop and deliver training for complaint management system users and regulatory reporting.

Skills

Quality Assurance

Regulatory Knowledge

Project Management

Communication

Process Improvement

Education

Bachelor's or Master's in technical, scientific, or engineering disciplines

Job description

Johnson & Johnson is seeking a PQV Combination Product Analyst IV to manage high-volume E2E complaint handling and MDR assessments. The role collaborates with Global Medical Safety, LOCs, and manufacturing sites to ensure compliant investigations and regulatory reporting, while guiding junior PQV staff and coordinating with external partners.

Requirements include a Bachelor’s or Master’s in a technical/scientific field and strong regulatory knowledge, with up to 5-10% travel across regions.