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Overview
For our client Roche Diagnostics International, the global market leader in in-vitro diagnostics based in Rotkreuz (ZG), we are looking for a motivated team player with proven experience in medical device and/or IVD product labeling as well as in Quality Management Systems. Instrument Integration Engineer (a) – partly remote
Responsibilities
Labeling Strategy & Execution: Spearheading the development and implementation of comprehensive labeling strategies for the IVD instrument transfer, ensuring full compliance with global regulatory requirements (e.g., EU IVDR, FDA, NMPA etc.) and Roche internal standards
Driving QMS-Related Changes: Managing and overseeing all QMS-related documentation and process updates necessitated by the manufacturing site transfer, including procedures, work instructions, and records, to maintain a robust and compliant quality system
Cross-Functional Collaboration: Acting as the primary liaison between various stakeholders, including Regulatory Affairs, Quality Assurance, R&D, Supply Chain, and the transferring/receiving manufacturing sites, to ensure alignment and effective execution of labeling and compliance activities
Risk Assessment & Mitigation: Identifying potential compliance risks associated with the transfer, developing mitigation strategies, and actively resolving any issues related to labeling and QMS changes
Documentation: Ensuring all labeling artwork, technical documentation, and QMS records are accurately developed, reviewed, approved, and maintained
Project Management Support: Contributing actively to project timelines, milestones, and deliverables for the instrument transfer, specifically focusing on the compliance and labeling work packages
Continuous Improvement: Proactively identifying opportunities to enhance existing labeling processes and QMS elements, fostering a culture of continuous improvement within the Subchapter Compliance Support
Qualifications
Bachelor's or Master's (open to PhD) degree in a scientific, engineering, or regulatory discipline
Min. 1 year proven experience in medical device/IVD product labeling and/or Quality Management Systems within the healthcare or life science industry
Demonstrated experience in managing and overseeing QMS-related documentation (e.g., procedures, work instructions, records) required to maintain a compliant quality system
Solid understanding of core global IVD/Medical Device regulations and standards (EU IVDR, FDA 21 CFR Part 820, ISO 13485)
Experience with product transfers or significant change management is highly advantageous
Practical experience and understanding of Good Manufacturing Practice (GMP) principles and their application within a regulated environment
Language Skills: Fluency in English and German B2 (written and spoken)
Application
Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Nazim Sagkol (B. Eng.), (+41 76 349 85 07)
Company & Locations
Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people’s lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.
Seniority level
Associate
Employment type
Full-time
Job function
Engineering and Quality Assurance
Industries
Medical Equipment Manufacturing
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