Descrição da Função

The company you'll be working for

A medical device manufacturing company is looking to recruit a Quality and Regulatory Affairs Technician (m/f/d).

Your new role

Reporting to the Quality Department, your main responsibilities will be:

- Manage the implementation of the New Medical Devices Regulation (EU) 2017/745 for the product portfolio including all activities related to regulatory aspects (Clinical Evaluation, Biological Evaluation, Risk Management, PMS, PMCF and other related);

- Provide technical support in the management of Quality Management System processes within the organization's processes in line with ISO13485 and its related activities.

What you need to succeed

- Degree in Biomedical Engineering, Biology, Biotechnology or related areas;

- Excellent knowledge of Medical Device Regulation (MDR) with experience in the manufacture of Medical Devices - risk class I sterile and IIa (Mandatory);

- Experience and autonomy in drawing up technical documentation for medical devices in accordance with the MDR for systems and assemblies;

- Experience and autonomy in the area of Quality systems management (ISO13485) and the regulatory area of medical device manufacturing;

- Advanced written and spoken English (Mandatory);

- Organized, detail-oriented, proactive and persevering profile.

 

What the company can offer you

Opportunity to join a challenging project in a leading company.

Next step

If you are interested in this opportunity, please send us your updated CV. If you're looking for another type of professional challenge, contact us to discuss other career opportunities, always in complete confidence.

Contacto

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