R&D Compliance Specialist

Michael Page ouvre un poste de R&D Compliance Specialist a CH.

Our client is seeking an experienced R&D Compliance Specialist to serve as the primary Quality and Compliance expert within a multidisciplinary R&D organization. This role will ensure that product lifecycle activities, engineering changes, and compliance processes meet the highest quality and regulatory standards while supporting innovative healthcare technologies.
R&D Compliance Specialist
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.
Description
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Act as the primary Quality and Compliance representative for the Disposable Kits R&D team.
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Ensure Design Control and Quality Management System requirements are applied throughout product development and lifecycle activities.
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Provide compliance guidance for engineering changes, product modifications, and sustaining activities.
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Review and support Design Control documentation, including design reviews, risk management files, and change control records.
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Support the planning and execution of Verification and Validation (V&V) activities.
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Conduct or support compliance assessments related to product, process, supplier, and documentation changes.
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Lead or participate in investigations involving deviations, non-conformances, complaints, and CAPAs.
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Collaborate closely with Regulatory Affairs, Quality, Manufacturing, and R&D stakeholders.
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Promote audit readiness and support regulatory inspections when required.
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Drive continuous improvement initiatives related to Design Control, Quality, and Compliance processes.
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Provide training, coaching, and guidance to project teams on quality and regulatory expectations.
Profile
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Academic degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field.
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6 years of expertise in Quality Assurance, Design Assurance, R&D Compliance, or Product Development Quality within a regulated industry.
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Strong expertise in Design Controls, Change Control, Risk Management, Verification & Validation, and Product Lifecycle Management.
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Good understanding of medical device and/or biopharmaceutical quality and regulatory requirements.
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Knowledge of regulations and norms : ISO 13485, FDA 21 CFR Part 820, and EU MDR principles.
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Experience working within Quality Management Systems supporting product development and sustaining activities.
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Familiarity with CAPAs, deviations, non-conformances, complaint investigations, and post-market quality processes.
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Background participating in audits and regulatory inspections is highly advantageous.
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Strong analytical, problem-solving, and risk assessment capabilities.
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Ability to work independently while effectively influencing and coordinating cross-functional teams.
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Excellent communication and stakeholder management skills.
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Fluent in English; French is a strong advantage.
Job Offer
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Opportunity to contribute to innovative products that support the development of life-changing therapies.
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Dynamic and collaborative international R&D environment with broad stakeholder exposure.
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Collaborative culture and engaging cross-functional teamwork.

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