R&D Compliance Specialist

- Drive compliance for innovative healthcare products. - Grow in a collaborative, cross-functional R&D environment.

Our client is a global leader in the life sciences and bioprocessing industry, delivering innovative technologies. Operating in a highly regulated environment, the company is committed to quality, compliance, and continuous innovation across its product portfolio. Job 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. The Successful Applicant - 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. What's on 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.