.
Regulatory Affairs Specialist
  • Gdynia
Regulatory Affairs Specialist
Gdynia, Gdynia, Pomeranian Voivodeship, Polska
Wilandt
25. 2. 2025
Informacje o stanowisku

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

First name:

Last name:

E-mail:

Phone number:

Choose file.

I consent to the processing of my personal data contained in this document for the purposes of the recruitment process pursuant to the Personal Data Protection Act of 10 May 2018, which incorporates the provisions of the European Unions General Data Protection Regulation (GDPR) (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and repealing Directive 95/46/EC (General Data Protection Regulation).

#J-18808-Ljbffr

  • Praca Gdynia
  • Gdynia - Oferty pracy w okolicznych lokalizacjach


    91 114
    11 909