Regulatory Affairs Manager EU (m/f/d)
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What you'll do
- You prepare and submit applications for conformity assessments and clinical trials involving non-active implantable class III medical devices in the EU.
- You coordinate timely and accurate responses to questions from Notified Bodies and Competent Authorities.
- You compile, assess, and update CE technical documentation and clinical trial application dossiers, including documentation provided by third parties.
- You advise cross-functional development teams on quality, analytical, preclinical, and clinical requirements to support the acceptance of regulatory submissions.
- You prepare and maintain product information in accordance with company core data, applicable legislation, and relevant guidelines.
- You manage the regulatory life cycle of CE-marked products, including renewals, change notifications, and annual updates.
- You assess regulatory implications of changes proposed by production sites, marketing teams, and other internal stakeholders.
- You coordinate regulatory projects and collaborate with external partners, including consultants, contract research organizations, and distribution partners.
- You develop regulatory strategies, contribute to cross-functional project teams, and serve as a contact person for regulatory requirements.
- You identify country-specific requirements and manage the submission and maintenance of documentation required in EU countries beyond the CE mark.
- You support additional regulatory activities and responsibilities as required.
What they're looking for
- You hold a degree in natural sciences, pharmacy, biology, chemistry, engineering (medical devices / bioengineering), or a comparable discipline, ideally at master’s or PhD level.
- You bring approximately 1-3 years of professional experience in EU regulatory affairs for medical devices.
- You have a sound understanding of the European regulatory landscape for medical devices.
- You demonstrate strong time management, problem-solving, communication, and digital skills.
- You work independently, remain resilient, and approach challenges with a structured and solution-oriented mindset.
- You collaborate effectively across functions and are able to coordinate projects and influence stakeholders without direct authority.
- You build constructive relationships with internal and external partners, including Notified Bodies and Competent Authorities.
- You communicate fluently and confidently in business English.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Merz Aesthetics is an independent, internationally active company in the field of aesthetic medicine. For years, our comprehensive product portfolio is among the highest quality in its category and is valued by healthcare professionals worldwide. Merz Aesthetics is part of the Merz Group, with our Europe , Middle East and Africa (EMEA) headquarters in Frankfurt am Main. Our global head office is located in Raleigh, North Carolina, USA. Our purpose is to help people look better, feel better, and live better, and over 3,000 employees across 26 countries are dedicated to this mission. Would you like to become part of our success story? Join Merz Aesthetics!
This role is limited to 18 months.
- You prepare and submit applications for conformity assessments and clinical trials involving non-active implantable class III medical devices in the EU.
- You coordinate timely and accurate responses to questions from Notified Bodies and Competent Authorities.
- You compile, assess, and update CE technical documentation and clinical trial application dossiers, including documentation provided by third parties.
- You advise cross-functional development teams on quality, analytical, preclinical, and clinical requirements to support the acceptance of regulatory submissions.
- You prepare and maintain product information in accordance with company core data, applicable legislation, and relevant guidelines.
- You manage the regulatory life cycle of CE-marked products, including renewals, change notifications, and annual updates.
- You assess regulatory implications of changes proposed by production sites, marketing teams, and other internal stakeholders.
- You coordinate regulatory projects and collaborate with external partners, including consultants, contract research organizations, and distribution partners.
- You develop regulatory strategies, contribute to cross-functional project teams, and serve as a contact person for regulatory requirements.
- You identify country-specific requirements and manage the submission and maintenance of documentation required in EU countries beyond the CE mark.
- You support additional regulatory activities and responsibilities as required.
- You hold a degree in natural sciences, pharmacy, biology, chemistry, engineering (medical devices / bioengineering), or a comparable discipline, ideally at master’s or PhD level.
- You bring approximately 1-3 years of professional experience in EU regulatory affairs for medical devices.
- You have a sound understanding of the European regulatory landscape for medical devices.
- You demonstrate strong time management, problem-solving, communication, and digital skills.
- You work independently, remain resilient, and approach challenges with a structured and solution-oriented mindset.
- You collaborate effectively across functions and are able to coordinate projects and influence stakeholders without direct authority.
- You build constructive relationships with internal and external partners, including Notified Bodies and Competent Authorities.
- You communicate fluently and confidently in business English.
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!
Company
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