Regulatory Affairs Specialist Medical Devices International Markets

Vor 4 Tagen

Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH Vollzeit
Job Description:

We are seeking a highly skilled Regulatory Affairs Specialist to support the development, achievement, and maintenance of marketing authorizations/registrations for medical devices in international markets. This role will involve preparing and submitting applications for new marketing authorizations/registrations, responding to questions in a timely and accurate manner, and compiling high-quality dossiers for marketing authorizations/registrations.

Responsibilities:
  • Prepare and submit applications for new marketing authorizations/registrations.
  • Respond to questions in a timely and accurate manner.
  • Compile and update high-quality dossiers for marketing authorizations/registrations.
  • Advise concerned development departments regarding quality, analytical methods, pre-clinical and clinical development to ensure acceptance of data worldwide.
  • Maintain and manage the lifecycle of products worldwide, including preparation and submission of applications for renewals, variations, submissions, and annual reports in due time.
  • Coordinate change control procedures, including collection of regulatory assessments worldwide and their international implementation.
  • Coordinate regulatory projects and communicate with third parties concerning regulatory issues.
  • Develop regulatory strategies and participate in project teams.
  • Evaluate (new) IT tools to support and facilitate product registration and maintenance as well as maintain regulatory databases to ensure they are correct and up-to-date.
  • Conduct due diligence for established products with regards to regulatory aspects.
Requirements:
  • Natural scientific or medical device engineering background (e.g., pharmacist, biologist, chemist) with approbation, diploma, master's degree, or PhD.
  • Approximately 2+ years of experience in the international regulatory affairs field for medical devices.
  • Experience in the registration of high-risk devices (class III).
  • Ideal experience in medical device registrations in Commonwealth of Independent States (CIS) countries/Eurasian Economic Union, e.g., Russia, Ukraine, Balkan countries.
  • Excellent written, oral, and interpersonal communication skills in English, with additional languages being an advantage.
  • Microsoft Office skills, as well as high affinity for IT tools.
  • Strategic and analytical thinking abilities.
  • Work in a highly structured manner.
  • Networking abilities with internal and external partners.
What We Offer:

We offer a competitive salary of €80,000 - €100,000 per year, depending on qualifications and experience. Our company prioritizes work-life harmony, offering flexible working hours and mobile working. We also provide ongoing training opportunities to foster personal and professional development. Join Merz Aesthetics GmbH, where we put people first and strive for excellence in aesthetic medicine.

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