For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Labeling and Compliance Specialist.<\/p>\n
Background:<\/strong> The Perfect Candidate:<\/strong> Tasks & Responsibilities:<\/strong> Must Haves:<\/strong> Reference Nr.: 924509<\/strong> If this position has piqued your interest, please send us your complete application. If this position doesn’t match your profile and you’d like to apply directly for another position, you can also send us your application via this advertisement or to jobs[at]itcag[dot]com. About us: Labeling and Compliance Specialist (m\/f\/d)- Medical\/ IVD Product Labeling\/ Quality Management Systems\/ healthcare\/ life science\/ EU IVDR\/ FDA 21 CFR part 820\/ ISO 13485\/ GMP\/ English\/ German Project: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Labeling and Compliance Specialist. Background:Are you a compliance expert with a […]<\/p>\n","protected":false},"author":0,"template":"","wpbb_job_industry":[17],"wpbb_job_location":[18],"wpbb_job_type":[7],"wpbb_job_skill":[],"yoast_head":"\n
Are you a compliance expert with a knack for precise labeling and a passion for ensuring product integrity? Roche Diagnostics Global Operations is seeking a dedicated and proactive Labeling and Compliance Specialist to join our Subchapter of Compliance Support team in Rotkreuz, Switzerland or Mannheim, Germany. In this pivotal role, you will be working with other members in our sub-chapter in ensuring seamless product labeling and process integration during the transfer of a key In-Vitro Diagnostic (IVD) instrument from one manufacturing site to another. This is an exciting opportunity to lead critical compliance activities, impact patient safety, and contribute directly to our mission of advancing healthcare.<\/p>\n
\u25cfExperience: Proven experience in medical device\/IVD product labeling and\/or Quality Management Systems within the healthcare or life science industry. Experience with product transfers or significant change management is highly advantageous.
\u25cfRegulatory Knowledge: In-depth understanding of relevant global regulations and standards for IVDs (e.g., EU IVDR, FDA 21 CFR Part 820, ISO 13485, NMPA).
\u25cfDetail-Oriented: Exceptional attention to detail and accuracy, particularly in reviewing and managing complex documentation.
\u25cfProject Management Skills: Strong organizational skills with the ability to manage multiple priorities and drive projects to completion in a fast-paced environment.
\u25cfCommunication & Collaboration: Excellent written and verbal communication skills, with the ability to effectively collaborate with diverse teams and influence stakeholders at all levels.
\u25cfProblem-Solving: Proactive and pragmatic approach to problem-solving, with a focus on delivering compliant and effective solutions.<\/p>\n
\u25cf 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.
\u25cfDriving 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.
\u25cf 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.
\u25cf 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.
\u25cfDocumentation: Ensuring all labeling artwork, technical documentation, and QMS records are accurately developed, reviewed, approved, and maintained.
\u25cf Project Management Support: Contributing actively to project timelines, milestones, and deliverables for the instrument transfer, specifically focusing on the compliance and labeling work packages.
\u25cf Continuous Improvement: Proactively identifying opportunities to enhance existing labeling processes and QMS elements, fostering a culture of continuous improvement within the Subchapter Compliance Support.<\/p>\n
\u25cfBachelor’s or Master’s (open to PhD) degree in a scientific, engineering, or regulatory discipline.
\u25cfMin. 1 year proven experience in medical device\/IVD product labeling and\/or Quality Management Systems within the healthcare or life science industry.
\u25cfDemonstrated experience in managing and overseeing QMS-related documentation (e.g., procedures, work instructions, records) required to maintain a compliant quality system.
\u25cfSolid understanding of core global IVD\/Medical Device regulations and standards (EU IVDR, FDA 21 CFR Part 820, ISO 13485)
\u25cfExperience with product transfers or significant change management is highly advantageous.
\u25cfPractical experience and understanding of Good Manufacturing Practice (GMP) principles and their application within a regulated environment.
\u25cfLanguage Skills: Fluency in English and German B2 (written and spoken).<\/p>\n
Role: Labeling and Compliance Specialist (m\/f\/d)<\/strong>
Industrie: Pharma<\/strong>
Workplace: Rotkreuz <\/strong>
Pensum: 80 – 100% <\/strong>
Start: Asap<\/strong>
Duration: 12++ Months<\/strong>
Deadline: 14.01.2026<\/strong><\/p>\n
For more information about our company, our positions, or our attractive payroll-only program, please contact us: +41 41 760 77 01.<\/p>\n
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for temporary staffing in the IT, life sciences, and engineering sectors. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we also do not charge any additional fees for payroll.<\/p>\n<\/p>\n![](\"https:\/\/counter.adcourier.com\/Z29waS4xMjEyOS4xMjMzOUBpdGVjaC5hcGxpdHJhay5jb20.gif\")
<\/p>\n","protected":false},"excerpt":{"rendered":"