Regulatory Affairs Specialist Medical Devices EU

Vor 2 Tagen

Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH Vollzeit
About the Position

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.

Key Responsibilities
  • Assist in the preparation and submission of applications for conformity assessment and clinical trials of non-active implantable medical devices in the EU.
  • Support the compilation of responses to questions from Notified Bodies and Competent Authorities in a timely and accurate manner.
  • Contribute to the assessment of dossiers of third parties and provide advice to development departments regarding quality, analytical methods, pre-clinical, and clinical development.
  • Assist in the preparation and update of product information texts according to company core data and relevant guidelines.
  • Support the maintenance and life-cycle management of the CE mark.
  • Contribute to the regulatory assessment of changes proposed by production centers, marketing departments, and other stakeholders.
  • Support the coordination of regulatory projects and communicate with third parties regarding regulatory issues.
Requirements
  • Natural scientific background (pharmacist, biologist, chemist, etc.) with approbation, diploma, master degree, or PhD.
  • Approximately 1 year of experience in EU regulatory affairs for medical devices.
  • First knowledge of the European regulatory landscape and networking abilities with internal and external partners.
  • Business fluent in English, additional languages a plus.
What We Offer

At Merz Aesthetics GmbH, we value our employees and offer a dynamic work environment with opportunities for growth and development. Our company culture is built on collaboration, innovation, and a commitment to excellence. We offer a competitive salary and benefits package, as well as opportunities for professional development and training.

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application.

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