Senior Medical Device Quality & Regulatory Lead

Integra LifeSciences Corporation; Schweiz; On-site; CHF 140,000 - 190,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Quality Compliance Manager to oversee the Quality Management System across site operations. You will lead complaint handling, CAPA, audits, and training programs to ensure ISO 13485, FDA, EU MDR compliance and patient safety.

The role requires a Master’s degree in Life Sciences and at least 10 years in medical device/pharma environments, with strong leadership and cross-functional collaboration skills. Fluent English and French are preferred.

Qualifications

• Master’s degree in Life Sciences or an equivalent field.
• 10+ years of experience in medical device or pharmaceutical manufacturing environments.
• Strong knowledge of ISO 13485, 21 CFR Part 820, EU MDR and related standards.

Responsibilities

• Lead complaint management, investigations, and CAPA activities with timely closure.
• Manage site internal audits and annual audit program compliance.
• Ensure quality systems, document control, training, and regulatory readiness.
• Coordinate Health Impact Assessments and cross-functional quality initiatives.
• Coach and develop Quality Engineers and Technicians; drive continuous improvement.

Skills

Quality management

CAPA management

Audit management

Regulatory compliance

Leadership

Cross-functional collaboration

Education

Master’s degree in Life Sciences

Tools

PLM

LMS

Job description

Integra LifeSciences Corporation is seeking a Quality Compliance Manager to oversee the Quality Management System across site operations. You will lead complaint handling, CAPA, audits, and training programs to ensure ISO 13485, FDA, EU MDR compliance and patient safety.

The role requires a Master’s degree in Life Sciences and at least 10 years in medical device/pharma environments, with strong leadership and cross-functional collaboration skills. Fluent English and French are preferred.