R&D Compliance Specialist

Description

• Act as the primary Quality and Compliance representative for the Disposable Kits R&D team.
• Ensure Design Control and Quality Management System requirements are applied throughout product development and lifecycle activities.
• Provide compliance guidance for engineering changes, product modifications, and sustaining activities.
• Review and support Design Control documentation, including design reviews, risk management files, and change control records.
• Support the planning and execution of Verification and Validation (V&V) activities.
• Conduct or support compliance assessments related to product, process, supplier, and documentation changes.
• Lead or participate in investigations involving deviations, non-conformances, complaints, and CAPAs.
• Collaborate closely with Regulatory Affairs, Quality, Manufacturing, and R&D stakeholders.
• Promote audit readiness and support regulatory inspections when required.
• Drive continuous improvement initiatives related to Design Control, Quality, and Compliance processes.
• Provide training, coaching, and guidance to project teams on quality and regulatory expectations.

Profile

• Academic degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field.
• 6 years of experience in Quality Assurance, Design Assurance, R&D Compliance, or Product Development Quality within 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 and regulatory requirements.
• Knowledge of regulations and norms : ISO 13485, FDA 21 CFR Part 820, and EU MDR principles.
• Experience working within Quality Management Systems supporting product development and sustaining activities.
• Familiarity with CAPAs, deviations, non-conformances, complaint investigations, and post-market quality processes.
• Experience participating in audits and regulatory inspections is highly advantageous.
• Strong analytical, problem-solving, and risk assessment capabilities.
• Ability to work independently while effectively influencing and coordinating cross-functional teams.
• Excellent communication and stakeholder management skills.
• Fluent in English; French is a strong advantage.

Job Offer

• Opportunity to contribute to innovative products that support the development of life-changing therapies.
• Dynamic and collaborative international R&D environment with broad stakeholder exposure.
• Collaborative culture and engaging cross-functional teamwork.