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Associate Regulatory Affairs Manager Medical Devices EU (m/f/d) at Merz Aesthetics GmbH | softgarden

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

• Full Time
• Hybrid
• Eckenheimer Landstraße 100, 60318 Frankfurt am Main, Deutschland
• Without Professional Experience
• 9/13/24

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!

About the position

As Associate Regulatory Affairs Manager Medical Devices EU (m/f/d), you support the preparation, submission and maintenance of marketing authorizations/registrations for medical devices in the EU taking into account the relevant legislation and regulatory guidelines.                                                        

The position is initially limited to 12 months.

The following responsibilities are awaiting you:

• You assist the preparation and submission of applications for conformity assessment/clinical trials of non-active implantable medical devices in the EU.


• You support the compilation of responses to questions from Notified Bodies and Competent Authorities in a timely and accurate manner.


• You help in the compilation and update of CE-dossiers for registrations/clinical trial applications (CTA).


• You provide advice to concerned development departments regarding the quality, analytical methods, pre-clinical, and clinical development to ensure acceptance of the data in the EU.


• You contribute to the assessment of dossiers of third parties.


• You assist in the preparation and update of product information texts according to company core data and relevant guidelines.


• You support the maintenance/Life-Cycle Management of the CE mark.


• You help in the preparation and submissions of applications for renewals, change notifications, annual updates, etc., in due time.


• You contribute to the regulatory assessment of changes proposed by the production centers, marketing departments, etc.


• You support the coordination of regulatory projects.


• You communicate with third parties (e.g., consultants, CROs, distribution partners) concerning regulatory issues.


• You manage regulatory consultants and help with the development of regulatory strategies.


• You participate in project teams.


• You act as the contact person with regards to regulatory requirements.


• You support the conduct of Due Diligences for established products with regards to regulatory aspects.

What we expect from you:

• You have a natural scientific background (pharmacist, biologist, chemist, etc.), approbation, diploma, master degree, or PhD.


• You have approximately 1 year of experience in EU regulatory affairs for medical devices.


• You possess first knowledge of the European regulatory landscape.


• You have networking abilities with internal and external partners (health authorities).


• You are knowledgeable in relevant methods.


• You exhibit analytical thinking.


• You have a structured way of working.


• You are business fluent in English, additional languages are a plus.

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

We look forward to your application!