We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations....+ ←

Bad Homburg / Hessen · Permanent · Full-time · As of now

Regulatory Affairs Operations Expert Enteral Nutrition (m/f/d)

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

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Ihr Kontakt

Swantje Kohl
Fresenius Kabi Deutschland GmbH
Bad Homburg
Kennziffer R-10014181

Einsatzbereich:

Legal, Compliance & Audit

Arbeitsverhältnis:

Vollzeit

Unternehmensbereich:

Fresenius Kabi Deutschland GmbH

Standort:

Bad Homburg / Hessen

Bewerbungsfrist:

keine – Wir freuen uns auf Ihre Bewerbung

More information

Information about the application process

Our offer at a glance

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.
fresenius-kabi.com

We seek talents and perspectives

At Fresenius, we are convinced that combining different perspectives, opinions, experiences, cultures and values enables us to harness the potential that will make us even more successful. All job applicants are welcome.

All terms used in this job advertisement to denote persons refer to all genders equally.

#careerswithapurpose at Fresenius

Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.