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Regulatory Affairs Specialist
Junior
Part-Time
Hutnicza 15B, Gdynia
Your responsibilities:
  • Preparation and updating of technical documentation of medical devices, supervision of documentation
  • Conducting the process of certification and registration of medical devices, including in foreign markets
  • Supervision of products in distribution
  • Creating documentation of clinical trials of medical devices, coordinating trials
  • Communication with authorities, experts, scientific institutions, foreign contractors on registration matters, new product development, etc.
  • Knowledge of legislation in the area of medical devices, keeping abreast of changes and their implications for ongoing projects
  • Preparation of texts for packaging materials and instructions for use, support in the preparation of marketing materials
  • Work with R&D and other departments on new product development

Expectations:
  • University education - biotechnology, pharmaceutical, chemical, biological or related fields
  • Experience in a position related to the registration of medical devices/medical products or in a position related to the organization and coordination of clinical trials
  • Experience in searching medical literature databases and evaluating scientific publications
  • Ability to communicate freely in English, evaluate scientific literature and create registration documentation
  • Accuracy, regularity
  • Ability to organize own work effectively
  • Ability to think analytically and solve problems
  • Willingness to independently seek and analyze information

We offer:
  • Stable and secure employment conditions based on an employment contract
  • Work tools adequate to the position held
  • Professional development through training
  • Participation in challenging projects
  • Openness to submitting your own ideas

Join our team