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Regulatory affairs operations expert enteral nutrition (m/f/d)

Fresenius Medical Care
Inserat online seit: 19 Dezember
Beschreibung

Your responsibilities: Point of contact for Regulatory Affairs colleagues with focus on Latin America regarding product registrations, including guidance on responding to deficiency letters and regulatory authority inquiries Coordination of national new product applications, line extensions as well as variations or renewals of existing products Clarification of local registration requirements and development of regulatory strategies to support product registration processes Preparation, review and updating of standard regulatory documentation (e.g., list of ingredients, nutrition information), as well as creation of country-specific registration documents Collaboration with internal interfaces (Quality, Research & Development, Medical Scientific Affairs, Marketing) to ensure timely and compliant submissions Active participation in project teams for food law evaluation and regulatory consulting in projects involving product changes, optimisations or line extensions Continuous development of Regulatory Intelligence for the Latin American markets to stay up to date and compliant with regulatory requirements Review and approval of labels and support in creating country-specific labels Your profile: Completed university degree in Life Sciences, Food Chemistry, Food Technology or a comparable field At least 8 years of professional experience in the regulatory field of the food industry, ideally with a focus on product registrations Profound knowledge of Codex Alimentarius standards for foods for special dietary uses and EU food regulations Fluent English skills, both written and spoken; Spanish is considered an asset Excellent proficiency in MS Office (Excel, Teams, PowerPoint, Word) Confident handling of document management systems and databases Service-oriented and detail-focused, with strong analytical thinking High level of quality awareness Affinity for working with digital systems and tools Strong team player with a collaborative mindset Excellent organisational and communication skills Experience in intercultural project teams and willingness to travel Mindesteingruppierung/Minimum Grading: E11

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