INT-095918

Labeling and Compliance Specialist

  • Zugo

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  • Farmaceutico / Biotecnologie / Chimica

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  • Full-time temporaneo

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

 

For our client Roche Diagnostics in Rotkreuz, we are looking for a motivated and reliable (m/f/d)

 

Labeling and Compliance Specialist 80-100%


Descrizione della missione

  • 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.

Profilo richiesto

  • 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 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).


Start Date: 05.01.2026 - latest: 01.02.2026
Planned Duration: 12 months 
Extension (for temporary contracts): rather likely
Home Office: yes, with 1-2 days in the office / week
Travel: max. 2 times a year

Are you interested and would you like to seize this opportunity? Then we should definitely get to know each other!  Simply click on "Apply now" and we look forward to receiving your complete application documents.


Il vostro contatto

  • home FLEXSIS - BASEL LIFESCIENCE
  • personFlorian Schuster
  • quick_reference_allRiferimento: INT-095918
  • calendar_todayPubblicato il:
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