Regulatory Affairs Manager (m/f/d), Medical Device Labeling

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 18 months. 

 

The following responsibilities are awaiting you:

• You coordinate translations of the core labeling data and approvals by local regulatory experts.
• You manage the translations in the labeling database (st4) and electronic data management system (Master Control).
• You coordinate and implement requirements from different departments such as Paralegal, Quality, and Marketing.
• You ensure compliance of labeling materials for medical devices with local labeling requirements.
• You organize and maintain electronic systems used by the labeling team (e.g., st4, eIFU/ePI website).
• You work closely with the labeling team, IT, and external vendors.
• You work closely with Supply Chain Planning and other relevant departments to ensure timely technical release and ready-to-print labeling material according to packaging and launch timelines.
• You support the maintenance/Life-Cycle Management in RoW by preparing and submitting applications for renewals, variations, submissions, annual reports, etc., in due time.
• You support the submission of applications for new marketing authorizations/registrations by providing harmonized and up-to-date product labeling materials.
• You support audits regarding label and translation management by preparing requested procedures and examples ahead of the audit as well as attend the relevant audit session if needed.
• You support the preparation of Master documents for certain markets as well as the creation of final artworks in print or electronic version.

What we expect from you:

• You have a university degree in natural sciences, languages, or an equivalent level of education.
• You have approximately 2 years of experience in labeling/regulatory roles within a life science environment and possess knowledge of product labeling regulations and guidance.
• You have strong attention to detail, with the ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
• You possess excellent organizational, and planning skills, with the ability to prioritize.
• You work independently on projects and initiatives internally and with external vendors.
• You are confident and able to influence key stakeholders.
• You are proficient in all MS Office applications and have experience in using databases.
• 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 https://careers.merz-aesthetics.com.

We look forward to your application!