Labeling and Compliance Specialist

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

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

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.

• 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 (e.g., 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.

• 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 Roche 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.

• 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 (e.g., procedures, work instructions, records) required to maintain a compliant quality system.
• Solid…