Regulatory Affairs Manager Medical Devices (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 1,600 employees in 36 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!
THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU:- Prepare and submit applications for new marketing authorizations/registrations and respond to questions from regulatory authorities in a timely and accurate manner.
- Compile and update dossiers for marketing authorizations/registrations, providing advice to development departments on quality, analytical methods, pre-clinical and clinical development to ensure acceptance of data worldwide.
- Assess dossiers of third parties and provide recommendations to internal stakeholders.
- Prepare and update product information texts according to company core data and relevant guidelines, managing translation processes.
- Conduct scientific advice meetings with regulatory authorities, ensuring appropriate preparation and conduct of meetings and effective communication with regulatory authorities worldwide.
- Manage worldwide maintenance/life-cycle management activities, including preparation and submission of applications for renewals, variations, annual reports, etc., in a timely manner.
- Coordinate change control procedures, including collection of regulatory assessments worldwide, and ensure international implementation.
- Handle regulatory projects, communicate with third parties such as consultants, CROs, and distribution partners on regulatory issues, and manage regulatory consultants as needed.
- Manage and align the development of regulatory strategies, participate in project teams, and serve as a contact person for regulatory requirements.
- Maintain regulatory databases and ensure accuracy and completeness of regulatory data.
- Conduct due diligence activities related to regulatory aspects.
- Bachelor's or Master's degree (PhD) in Pharmacy, Life Sciences, or related field
- Minimum of 3-6 years of experience in Regulatory Affairs in the pharmaceutical, biotechnology, or medical device industry.
- Business fluent English, knowledge of other foreign languages would be an advantage.
- Proficient in Microsoft Office and the use of databases and regulatory software tools.
- Knowledge of regulatory requirements and guidelines for global markets.
- Strong understanding of regulatory methods and processes related to medical devices.
- Skilled in compiling and updating dossiers, translation management and product information.
- Excellent ability to network with internal and external partners, including health agencies.
- Strong organizational skills with attention to detail and ability to work in a fast-paced environment.
- Ability to coordinate and manage multiple regulatory projects simultaneously.
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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 Employee Assistance Program.
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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. We have been awarded the “Family-Friendly Company” certificate from the Hertie Foundation for our commitment to family and work.
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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 flextime/trust-based working time and mobile working. Our employees also benefit from generous arrangements for annual leave.
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Ongoing training: Your personal and professional development is the key to success for us. To this end, we hold 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 here.
We are looking forward to your application!
You can find more information at https://merz-aesthetics.info/
