Our client is seeking an experienced R&D Compliance Specialist to serve as the primary Quality and Compliance expert within a multidisciplinary R&D team. This role will ensure product lifecycle activities, engineering changes, and compliance processes meet the highest quality and standards while supporting healthcare innovation. Our client is a global leader in the life sciences and bioprocessing industry, delivering technologies. In a highly regulated environment, the company is committed to quality, compliance, and continuous improvement across its product portfolio.Description- Act as the primary Quality and Compliance expert for the Disposable Kits R&D team.- Oversee Design Control and Quality Management System processes applied throughout product development and lifecycle activities.- Provide compliance guidance for engineering changes, product development, and sustaining activities.- Support Design Control 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 quality issues involving non-conformances, complaints, and CAPAs.- Collaborate closely with Regulatory Affairs, Quality, Manufacturing, and R&D stakeholders.- Promote audit readiness and support inspections when necessary.- Drive continuous improvement to Design Control, Quality, and Compliance processes.- Provide training, coaching, and guidance to project teams.Requirements- Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field.- 5+ years of experience in Quality Assurance, Design Assurance, R&D Compliance, or Product Development Quality within a regulated industry.- Expertise in Design Controls, Change Control, Risk Management, and Product Lifecycle Management.- Strong understanding of medical device and/or biopharmaceutical quality and regulatory requirements.- Knowledge of industry norms: ISO 13485, FDA 21 CFR Part 820, and EU MDR principles.- Experience working within Quality Management Systems for product development and sustaining activities.- Familiarity with CAPAs, non-conformances, complaint handling, and post-market quality processes.- Experience in audits and inspections is highly preferred.- Strong analytical, problem-solving, and risk assessment capabilities.- Ability to work independently while effectively influencing and leading cross-functional teams.- Excellent communication and stakeholder management skills in English; French is a strong asset.Offer- Opportunity to contribute to products that support the development of life-changing therapies.- Dynamic and innovative R&D environment with broad stakeholder exposure.- Collaborative culture and engaging cross-functional teamwork. jid67b1057aen jit0728aen jpiy26aen
Research And Development Compliance Specialist Arbeitgeber: Michael Page Switzerland
Notre client, une banque privée internationale bien établie en Suisse, offre un environnement de travail dynamique et à taille humaine, idéal pour les professionnels cherchant à évoluer dans le secteur financier. Avec des opportunités de collaboration étroite avec le Front Office et une culture proactive du risque, les employés bénéficient d'une atmosphère stimulante qui favorise la croissance personnelle et professionnelle. De plus, la diversité linguistique et l'expertise en crédit permettent de travailler sur des opérations complexes tout en développant des compétences précieuses dans un cadre international.
