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R&D Compliance Specialist

Genf Interim View Job Description
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.

hinzugefügt 10/07/2026

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

Firmenprofil



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.

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.



Anforderungsprofil

  • 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.



Sonstige Informationen

  • 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.



Referenznummer angeben
JN-072026-7060279

Zusammenfassung

Berufsfeld
Engineering & Produktion
Näheres Berufsfeld
Qualität, Technik
Branche
Healthcare / Pharmaceutical
Ort
Genf
Vertragsart
Interim
Referenznummer
JN-072026-7060279

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