Labeling and Compliance Specialist (m / f / d)

Labeling and Compliance Specialist

(m / f / d)

Freelance / temporary employment for a project Zug Start date : 01 / 26 Reference number : 845358 / 1

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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 (, 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

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