Regulatory Affairs Manager Medical Devices ROW (m/f/d) - #2116938

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

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  Full Time
  
• 
  Hybrid
  
• 
  Altenhöferallee 5, 60438, Frankfurt am Main
  
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  With Professional Experience
  
• 
  3/11/25
  

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 role is initially limited to 12 months.

The following responsibilities are awaiting you:

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  You prepare and submit applications for new marketing authorizations / registrations and respond to questions in a timely and accurate manner
  
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  You compile and update high-quality dossiers for m
  
  arketing authorizations / registrations
  
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  You advise concerned de
  
  velopment departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data worldwide
  
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  You maintain and manage the lifecycle of products worldwide, including the preparation and submission of applications for renewals, variations, submissions, and annual reports in due time
  
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  You coordinate change control procedures, including the collection of regulatory assessments worldwide and their international implementation
  
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  You coordinate regulatory projects and communicate with third parties concerning regulatory issues
  
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  You coordinate the development of regulatory strategies and participate in project teams
  
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  You evaluate (new) IT tools to support and facilitate product registration and maintenance as well as maintain the regulatory databases to ensure they are correct and up to date
  
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  You conduct due diligence for established products with regards to regulatory aspects
  
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  You prepare and update product information texts according to company core data and relevant guidelines and manage translations
  

What we expect from you:

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  You have a natural scientific or medical device engineering background (e.g., pharmacist, biologist, chemist), with approbation, diploma, master’s degree, or PhD
  
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  You have approximately 2+ years of experience in the internation
  
  al regulatory aff
  
  airs field for medical devices
  
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  You have experience in the registration of high-risk devices (class III)
  
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  You ideally have experience in medical device registrations in Latin America
  
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  You have excellent written, oral, and interpersonal communication skills in English, with additional languages, such as Spanish, being an advantage
  
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  You possess Microsoft Office skills, as well as a high affinity for IT tools
  
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  You have strategic and analytical thinking abilities
  
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  You work in a highly structured manner
  
• 
  You
  
  have 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 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!