Direct message the job poster from Coopers Group AG
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.
Your background
* Bachelor's, Master's, (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.
Seniority level
* Associate
Employment type
* Temporary
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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