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

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!

As Regulatory Affairs Manager Medical Devices ROW (m/f/d), you support develop, achieve and maintain marketing authorizations/registrations for medical devices in international markets, taking into account the relevant legislation and regulatory guidelines.

The position is initially limited to 12 months.

• You prepare and submit applications for new marketing authorizations / registrations and respond to questions in a timely and accurate manner.
• You compile and update high-quality dossiers for marketing authorizations / registrations.
• You advise concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data worldwide.
• 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.
• You coordinate change control procedures, including the collection of regulatory assessments worldwide and their international implementation.
• You coordinate regulatory projects and communicate with third parties concerning regulatory issues.
• You coordinate the development of regulatory strategies and participate in project teams.
• 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.
• You conduct due diligence for established products with regards to regulatory aspects.
• You prepare and update product information texts according to company core data and relevant guidelines and manage translations.

• You have a natural scientific or medical device engineering background (e.g., pharmacist, biologist, chemist), with approbation, diploma, master’s degree, or PhD.
• You have approximately 2+ years of experience in the international regulatory affairs field for medical devices.
• You have experience in the registration of high-risk devices (class III).
• You ideally have experience in medical device registrations in Commonwealth of Independent States (CIS) countries / Eurasian Economic Union, e.g., Russia, Ukraine, Balkan countries.
• You have excellent written, oral, and interpersonal communication skills in English, with additional languages being an advantage.
• You possess Microsoft Office skills, as well as a high affinity for IT tools.
• You have strategic and analytical thinking abilities.
• You work in a highly structured manner.
• You have networking abilities with internal and external partners.

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.

We look forward to your application!