Are you a compliance expert with a knack for precise labeling and a passion for ensuring product integrity?
For one of our Clients, a medical diagnostics company, we are looking for a dedicated and proactive Labeling and Compliance Specialist to join a Subchapter of Compliance Support team in Rotkreuz.
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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.
General Information:
- Start date: January 2026
- Latest start date: February 2026
- End date: 1 year
- Contract: temporary contract via Randstad
- Extension: likely
- Workplace: Rotkreuz
- Workload: 80-100%
- Home Office: up to 3 days / week
- Travel: up to 2x / year
- Working hours: standard
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.
Must Haves:
- Academic 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.
- Language Skills: Fluency in English and German B2 (written and spoken).
