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)