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.
Your Responsibilities
* 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.
Your Profile
* 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.
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