Labelling & Compliance Consultant

We are looking for a Consultant Labelling & Compliance to join our teams in Zug to support global labelling, regulatory compliance, and quality activities for in vitro diagnostic (IVD) products across their full lifecycle.

• Manage and coordinate IVD product labelling activities in alignment with applicable regulatory requirements, including IVDR (EU 2017/746), FDA, and other international regulations.
• Review, prepare, and maintain labels, Instructions for Use (IFU), and packaging texts, ensuring accuracy, consistency, and compliance with regulatory, clinical, and safety requirements.
• Ensure labelling content is compliant with ISO 13485, ISO 15223-1, ISO 20417, and client internal quality standards.
• Act as a key interface between Regulatory Affairs, Quality Assurance, R&D, Clinical, Manufacturing, and Supply Chain to ensure timely and compliant labelling updates.
• Support change control activities, including impact assessments related to labelling changes, regulatory updates, and product modifications.
• Contribute to regulatory submissions and technical documentation, ensuring labelling alignment within design dossiers and submission packages.
• Participate in compliance risk assessments, identifying potential gaps and proposing mitigation actions related to labelling and regulatory requirements.
• Support internal and external audits and inspections by providing labelling and compliance documentation and responding to auditor inquiries.
• Monitor and interpret evolving global regulatory and compliance requirements, proactively assessing their impact on existing and future products.
• Contribute to the continuous improvement of labelling processes, templates, SOPs, and compliance workflows.

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, or a related field.
• Proven experience in labelling, regulatory affairs, or compliance within the IVD or medical device industry.
• Solid knowledge of IVDR, FDA labelling requirements, and international regulatory frameworks for diagnostics.
• Strong understanding of Quality Management Systems (ISO 13485) and compliance-driven product lifecycle management.
• Experience working with change management, design control, and technical documentation.
• Ability to work in cross-functional, international environments with multiple stakeholders.
• Detail-oriented mindset with strong documentation, analytical, and organizational skills.
• Fluency in English;
  German is an advantage.