Labeling and Compliance Specialist

vor 1 Woche

Rotkreuz, Zug, Schweiz Hays Vollzeit

Your proven
experience in medical device/IVD product labeling and/or Quality Management Systems within the healthcare or life science industry
is required for this role.

General info:

  • Start Date: 05 January 2026, latest Possible Start Date: 01 February 2026
  • Planned Duration of Employment: 12 months, extension possible
  • Workplace: Rotkreuz
  • Workload: %

Tasks & 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 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

Qualification and skills

  • Bachelor's or Master's (open to PhD) degree in a scientific, engineering, or regulatory discipline
  • Proven initial
    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
  • Fluency in English and German B2 (written and spoken)

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