R&D Compliance Specialist

Michael Page International (Switzerland) SA; Genf; Vor Ort; CHF 130.000 - 180.000; Vollzeit

Zusammenfassung

Michael Page International (Switzerland) SA in Switzerland is seeking a dedicated Quality and Compliance representative for the Disposable Kits R&D team. You will ensure Design Control and Quality Management System requirements are applied throughout product development and lifecycle activities.

Collaborate with Regulatory Affairs, Quality, Manufacturing and R&D, provide guidance on changes, support V&V, audits, CAPAs, and drive continuous improvement in Design Control and Compliance processes.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

Design Controls

Regulatory Compliance

Risk Management

CAPA handling

Audit readiness

Cross-functional collaboration

Problem solving

Communication

Ausbildung

Engineering degree

Life Sciences degree

Biomedical Engineering

Quality Management

Tools

QMS software

Jobbeschreibung

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

About Our Client

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.