Regulatory Affairs Operations Expert Enteral Nutrition

Vor 4 Tagen

Bad Homburg EK, Deutschland Fresenius Vollzeit 60.000 € - 80.000 € pro Jahr
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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