Regulatory Affairs Manager APAC (m/f/d), Regulatory Affairs ROW

Merz Aesthetics GmbH; Frankfurt; Presencial; EUR 85.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible hours

Training programs

Global collaboration

Descripción de la vacante

Merz Aesthetics GmbH, located in Frankfurt, is seeking a Regulatory Affairs professional with 3–5 years of experience in international medical devices regulatory affairs. The role emphasizes high-risk Class III devices, global and APAC submissions, and regulatory strategy development.

The candidate will manage dossiers, labeling, and IFU reviews, monitor changing regulations, and collaborate with cross-functional teams to ensure compliance across markets, including audits and translations as

Formación

• 3–5 years of international Regulatory Affairs experience in medical devices.
• Experience with high-risk (Class III) devices.
• Knowledge of global and APAC regulations; submissions across APAC markets.
• Understanding regulatory pathways for energy-based systems, implants, injectables, and combinations.
• Experience preparing technical files, labeling, and IFU reviews.
• Monitor evolving regulatory requirements and develop compliance strategies.
• Knowledge of ISO 13485; experience supporting audits.
• Fluent English; Chinese/Japanese language skills are a plus.

Responsabilidades

• Prepare and submit applications for new marketing authorizations/registrations and respond to questions promptly.
• Compile and update high-quality dossiers for marketing authorizations/registrations.
• Advise development departments on quality, analytical methods, pre-clinical and clinical data for worldwide data acceptance.
• Manage lifecycle of products worldwide including renewals, variations, submissions, and annual reports.
• Coordinate change control procedures and collect regulatory assessments for global implementation.
• Coordinate regulatory projects and communicate with third parties regarding regulatory issues.
• Develop regulatory strategies and participate in project teams.
• Evaluate IT tools to support product registration and maintenance; maintain regulatory databases.
• Perform due diligence for established products regarding regulatory aspects.
• Prepare and update product information texts and manage translations.

Conocimientos

Regulatory affairs

English fluency

APAC regulations

Regulatory submissions

Medical device experience

Educación

Scientific/medical degree

Master’s or PhD preferred

Herramientas

Regulatory databases

Descripción del empleo

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!

The following responsibilities are awaiting you:

• 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 regard to regulatory aspects.
• You prepare and update product information texts according to company core data and relevant guidelines and manage translations.

What we expect from you:

• You have a natural scientific or medical device engineering background (e.g., pharmacist, biologist, chemist), with approbation, diploma, master’s degree, or PhD.
• You bring approximately 3–5 years of experience in international Regulatory Affairs within the medical device industry, with a strong focus on high-risk (Class III) medical devices.
• You have in-depth knowledge of global and APAC medical device regulations and hands‑on experience managing regulatory submissions, registrations, renewals, change notifications, and approvals across key APAC markets, including China, Japan, South Korea, Australia, Singapore, and Thailand.
• You understand regulatory pathways and requirements for medical devices, including energy-based systems, implants, injectables, and combination products.
• You are experienced in preparing and reviewing technical files and submission dossiers, labeling and IFU reviews, regulatory strategies and gap assessments.
• You proactively monitor evolving regulatory requirements and standards across APAC, assess the business impact of regulatory changes, and develop effective compliance strategies to support organizational objectives.
• You have a solid understanding of quality management systems and standards, such as ISO 13485, and ideally bring experience supporting audits, inspections, and interactions with regulatory authorities.
• You communicate fluently in English, and additional language skills in Chinese and/or Japanese would be a strong advantage.

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.