R&D Compliance Specialist in Genève

Overview

In this role you will serve as the primary Quality and Compliance representative for the Disposable Kits R&D team, ensuring Design Control and QMS requirements are applied across development and lifecycle activities. You will advise on engineering changes, product modifications, and sustaining work, while supporting V&V planning and execution. You will lead investigations into deviations, CAPAs, and non-conformances, and collaborate with Regulatory Affairs, QA, Manufacturing, and R&D to maintain audit readiness. You will drive continuous improvement in Design Control, Quality, and Compliance processes and coach project teams. This is an opportunity to shape quality excellence in a regulated,

Leistungen / Benefits

• opportunity to contribute to life-changing therapies
• international R&D environment
• collaborative culture and cross-functional teamwork

Verantwortungsbereiche

• Act as QA & Compliance representative for the R&D team
• Apply Design Control and QMS across product development and lifecycle
• Provide compliance guidance for changes and sustaining activities
• Review and support Design Control docs (design reviews, risk files, change records)
• Plan and execute Verification & Validation activities
• Conduct or support compliance assessments for product, process, supplier, and documentation changes
• Lead or participate in investigations (deviations, non-conformances, complaints, CAPAs)
• Collaborate with Regulatory Affairs, QA, Manufacturing, and R&D stakeholders
• Promote audit readiness and support regulatory inspections
• Drive continuous improvement of Design Control, Quality, and Compliance processes
• Provide training and coaching on quality and regulatory expectations

Zentrale Anforderungen

• Academic degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or related field
• 6 years of experience in QA/Design Assurance/R&D Compliance/Product Development Quality in a regulated industry
• Strong expertise in Design Controls, Change Control, Risk Management, Verification & Validation, and Product Lifecycle Management
• Good understanding of medical device and/or biopharmaceutical quality/regulatory requirements
• Knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR principles
• Experience with QMS supporting product development and sustaining activities
• Familiarity with CAPAs, deviations, non-conformances, complaint investigations, post-market quality
• Experience in audits/regulatory inspections is advantageous
• Strong analytical, problem-solving, and risk assessment skills
• Ability to work independently and influence cross-functional teams
• Excellent communication and stakeholder management
• Fluent in English; French a strong advantage

• excellent communication
• stakeholder management
• problem-solving
• Design Controls
• Change Control
• Risk Management