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Regulatory Affairs Specialist

Mid/regular

Full 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

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