Job Title: Regulatory Content Specialist
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This role is a Fixed term contract lasting 12 months. As the primary point of contact for internal and external customers in labeling, you are responsible for creating and maintaining labeling documents for medical devices according to international regulatory standards.
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Your key tasks include:
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* Creation and maintenance of content and design for labeling per international regulatory standards
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* Coordination of review and approval process, translation management, print release and publication
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* Support and manage internal New Product Development Projects, improvement projects, and regulatory compliance projects through their lifecycle from preparation and planning to successful completion
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* Streamlining and optimization of processes, implementing new or changed regulatory requirements
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* Managing NCs and CAPAs to maintain high quality standards
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Required qualifications:
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* Technical degree or certificate in a related field such as technical writer or engineer
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* Many years of relevant professional experience in labeling, quality, regulatory affairs, or R&D, preferably in the medical device, pharmaceutical, or other regulated industries
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* Experience in project management, leading processes from creation to release
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* Fluency in English and excellent knowledge of German and/or French
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* Resilience, reliability, and service orientation with the ability to work on complex issues in a timely and qualitative manner
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* Ease in integrating into an international work environment and collaborating with various teams
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