Labeling and Compliance Specialist (m/f/d)

As a first-tier supplier to our renowned business partner Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Labeling and Compliance Specialist for a temporary assignment of 12 month, with high probability of extension.

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.

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 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.

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 (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).

Benefits

• Work with state-of-the-art tools on a modern campus featuring green spaces and an inspiring atmosphere.
• Experience a work culture that promotes diversity and inclusion, where everyone feels valued.
• Benefit from financial support for your professional development and further education.
• Take advantage of unbeatable, year-round discounts with renowned retailers, over 200 top brands, as well as fleet discounts on new car purchases and consistent fuel discounts.
• Become part of one of the most renowned pharmaceutical companies and actively help shape the future of healthcare.
• Enjoy a selection of high-quality meals in modern staff restaurants.
• Where applicable, benefit from on-site parking as part of a sustainable mobility concept.
• Start with professional onboarding and a thorough introduction to your new role during the Welcome Days.
• We offer you a long-term position and diverse development opportunities within the company.

Are you interested? Don't hesitate and submit your complete application documents online today. We look forward to hearing from you!

Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.

Kontakt
Kristof Wildmann

Arbeitsort
Rotkreuz

Pensum
80 - 100%

Position
Mitarbeiter

Branche
Elektro + Mechanik