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Regulatory Affairs Specialist

vor 2 Monaten

Deggendorf, Bayern, Deutschland ADLINK Technology Vollzeit
Join Our Team as a Junior Manager Regulatory Affairs (f/m/x)

ADLINK Technology GmbH, a leading provider of embedded hardware and software solutions, is seeking a highly motivated Junior Manager Regulatory Affairs (f/m/x) to join our team in Deggendorf/Mannheim, Germany.

About the Role

We are looking for a talented individual to support our regulatory affairs team in ensuring compliance with international regulations and standards for our electrical products for medical devices. As a Junior Manager Regulatory Affairs, you will be responsible for preparing and updating technical documentation, handling international product registrations, and participating in post-market surveillance activities.

Key Responsibilities
  • Preparation and updating of technical documentation in an international context (Class 1 MD)
  • Handling of international product registrations in Europe (MDR) as well as in other relevant markets
  • Participation in post-market surveillance activities, including adverse event reporting and vigilance activities
  • Regulatory compliance: staying up-to-date with relevant regulations, directives, and standards (e.g., EU Medical Device Regulation, ISO)
Requirements
  • 2 years of experience working in Regulatory Affairs roles within the medical device industry, preferably active medical devices and software acc. to EN 62304
  • Solid knowledge of applicable regulations and standards, such as EU MDR, ISO 13485, FDA regulations, etc.
  • Understanding of risk management principles and methodologies
  • Communication skills, both written and verbal, with fluency in English and German
What We Offer
  • A long-term and permanent employment in an exciting international technology business environment
  • A competitive and attractive salary with a performance-based annual bonus
  • Opportunity for JobBike Leasing
  • Excellent working environment
  • International, intercultural, and collegial working environment

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity. Please provide an English CV with your application.