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Regulatory Affairs Manager Labeling EU/RoW (m/f/d)

Full Time
Frankfurt am Main, Deutschland
Experienced Professional
May 23, 2024
Hybrid
Regulatory Affairs Manager Labeling EU/RoW (m/f/d)

Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their categories and is highly regarded by healthcare professionals worldwide. As Merz Aesthetics, we are part of the Merz Group with our EMEA headquarters located in Frankfurt am Main, Germany. Our global head office is located in Raleigh, North Carolina, USA. Every day, more than 2,500 employees in 36 countries are committed to restoring and maintaining the skin's beauty. Would you like to become part of our success story? Then join Merz Aesthetics!

THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU:
  • Coordinate the development of regulatory strategies with regards to product information texts in compliance with regulatory requirements
  • Translation management of the core labeling, and coordination of the corrections and approvals of the language versions by local regulatory experts. Management of the translations in the labeling database
  • Coordination of change control procedures with regards to product information texts and their international implementation
  • Support the maintenance/Life-Cycle Management in EU and Rest of the World by providing harmonized and up to date product labeling materials
  • Work close with Supply Chain Planning in order to ensure a timely technical release and ready-to-print labeling material according to packaging and launch timelines
  • Develop and maintain SOPs and processes for review, approval and submission of labeling materials. Work closely with Legal, Medical Devices EU/ROW, and Marketing on improving and enhancing the review process
WHAT WE EXPECT FROM YOU:
  • University degree in Natural Sciences , professional interpreter with a focus on scientific/medical texts or similar qualification
  • 3-6 years of experience in international medical device labeling
  • Business fluent in English and German, further languages would be preferable
  • Proficiency in all MS Office applications
  • Strong attention to detail. Ability to review documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
  • Excellent organizational, prioritization and planning skills. Ability to work independently on projects
WHAT YOU CAN EXPECT FROM US:
  • Putting people first: You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics. You will collaborate with colleagues from all around the globe. And if life takes an unexpected turn and you need help or advice, then you can always rely on our Employee Assistance Program.

  • Family and work: Our employees should be able to reconcile their family and work commitments. That’s why you’ll find, for example, company day care centers at our locations. We have been awarded the “Family-Friendly Company” certificate from the Hertie Foundation for our commitment to family and work.

  • Work-life harmony: Our time is precious; our daily routines individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flextime/trust-based working time and mobile working. Our employees also benefit from generous arrangements for annual leave.

  • Ongoing training: Your personal and professional development is the key to success for us. To this end, we hold regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.

Find out more about our benefits here.

We are looking forward to your application!

You can find more information at https://merz-aesthetics.info/

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