R&D Compliance SpecialistMichael Page • Geneva, CH

R&D Compliance Specialist

Michael Page • Geneva, CH

Vor 16 Tagen

Stellenbeschreibung

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.

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.

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.

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R&D Compliance Specialist • Geneva, CH

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