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Regulatory Affairs Manager Medical Devices (f/m/d)

Full Time
Eckenheimer Landstraße 100, 60318 Frankfurt am Main, Deutschland
Experienced Professional
January 30, 2024
Hybrid
Regulatory Affairs Manager Medical Devices (f/m/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 1,600 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:
  • Preparation and submission of applications for new marketing authorisations/ registrations and of responses to questions in a timely and accurate manner
  • Compilation and update of dossiers for marketing authorisations/ registrations, advice to concerned development departments regarding the quality, anayltical methods, pre- clinical and clinical development to ensure acceptance of the data worldwide. Assessment of dossiers of third parties
  • Appropriate preparation and conduct of scientific advice meetings with regulatory authorities, communication with regulatory authorities worldwide
  • Maintenance/ Life- Cycle Management worldwide (preparation and submissions of applications for renewals, variations, submissions, annual reports etc. in due time)
  • Coordination of change control procedures (collection of regulatory assessments worldwide) and their international implementation
  • Coordination of regulatory projects, communication with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues, management of regulatory consultants
WHAT WE EXPECT FROM YOU:
  • Natural scientific or medical device engineering background (pharmacist, biologist, chemist, etc.) approbation, diploma, master degree or PhD
  • Approx. 3 -6 years of experience in international regulatory affairs field for medical devices
  • Experience in registration of high risk devices (class III)
  • Experience in medical device registration in Asia Pacific and Latin American countries
  • Fluency in Business English is a must - further foreign languages, especially Spanish
  • Microsoft Office skills
  • Networking abilities with internal and external partners
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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