Labeling and Compliance Specialist (m/f/d)

Labeling and Compliance Specialist (m/f/d)- Medical/ IVD Product Labeling/ Quality Management Systems/ healthcare/ life science/ EU IVDR/ FDA 21 CFR part 820/ ISO 13485/ GMP/ English/ German

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Labeling and Compliance Specialist.

Background:
Are you a compliance expert with a knack for precise labeling and a passion for ensuring product integrity? Roche Diagnostics Global Operations is seeking a dedicated and proactive Labeling and Compliance Specialist to join our Subchapter of Compliance Support team in Rotkreuz, Switzerland or Mannheim, Germany. 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.

The Perfect Candidate :
?Experience: Proven experience in medical device/IVD product labeling and/or Quality Management Systems within the healthcare or life science industry. Experience with product transfers or significant change management is highly advantageous.
?Regulatory Knowledge: In-depth understanding of relevant global regulations and standards for IVDs (EG, EU IVDR, FDA 21 CFR Part 820, ISO 13485, NMPA).
?Detail-Oriented: Exceptional attention to detail and accuracy, particularly in reviewing and managing complex documentation.
?Project Management Skills: Strong organizational skills with the ability to manage multiple priorities and drive projects to completion in a fast-paced environment.
?Communication & Collaboration: Excellent written and verbal communication skills, with the ability to effectively collaborate with diverse teams and influence stakeholders at all levels.
?Problem-Solving: Proactive and pragmatic approach to problem-solving, with a focus on delivering compliant and effective solutions.

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 (EG, EU IVDR, FDA, NMPA etc.) and Roche internal standards.
?Driving QMS-Related Changes: Managing and overseeing all QMS-related documentation and process updates required 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:
?Bachelor's or Master's (open to 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 (eg, 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).

Reference No .: 924509
Role: Labeling and Compliance Specialist (m/f/d)
Industry : Pharma
Workplace : Rotkreuz
Workload : 80 - 100%
Start : January 5th, 2026 (latest Start Date: February 1st, 2026)
Duration : 12 Months
Deadline : October 27th, 2025

If this position has piqued your interest, please send us your complete application. If this position doesn't match your profile and you'd like to apply directly for another position, you can also send us your application via this advertisement or to jobs[at]itcag[dot]com.
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About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for temporary staffing in the IT, life sciences, and engineering sectors. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we also do not charge any additional fees for payroll.