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Regulatory Affairs Manager (m/f/d)

Full Time
Altenhöferallee 5, 60438 Frankfurt am Main, Deutschland
Experienced Professional
June 24, 2024
Hybrid
Regulatory Affairs Manager (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 26 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!

This position is initially limited to 12 months.

The following responsibilities are awaiting you:
  • Preparation and submission of applications for conformity assessment/clinical trials of non-active implantable medical devices in the EU and responses to questions from Notified Bodies and Competent Authorities
  • Compilation and update of CE-dossiers for registrations/clinical trial applications (CTA), advice to concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data in EU as well as assessments of dossiers of third parties
  • Preparation and update of product information texts according to company core data and relevant guidelines
  • Maintenance/Life-Cycle Management of the CE mark (preparation and submissions of applications for renewals, change notifications, annual updates etc.)
  • Regulatory assessment of changes proposed by the production centers, marketing departments etc.
  • Coordination of regulatory projects, communication with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues, including management of regulatory consultants
  • Development of regulatory strategies, participation in project teams, functioning as contact person in regard to regulatory requirements
  • Conduct of Due Diligences for established products reagrding regulatory aspects
What we expect from you:
  • Natural scientific or medical device engineering background (pharmacist, biologist, chemist, etc.) approbation, diploma, master degree or PhD
  • Approx. 1-3 years of experience in EU Regulatory Affairs for medical devices
  • Knowledge of the European regulatory landscape
  • Fluency in Business English is a must - further foreign languages are welcome
  • Microsoft Office skills
  • Analytical and structured way of thinking
  • Networking abilities with internal and external stakeholders
What we expect from you:

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 different internal and external support systems.

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. In the EMEA region, we have been awarded the “Top Employer” and “Great Place to Work” certifications for our outstanding HR policies and work culture.

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 flex-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 foster this, we conduct 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 at https://careers.merz-aesthetics.com.

We look forward to your application!

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