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Role Overview

Manage and support regulatory processes for medical devices (primarily within the EU
MDR);
Prepare technical documentation for certification (CE marking);
Ensure compliance with applicable regulatory requirements;
Collaborate with internal teams (product, engineering, clinical) to ensure regulatory alignment;
Support and maintain the Quality Management System (QMS), ensuring compliance with standards such as ISO 13485;
Liaise with notified bodies and other regulatory authorities;
Monitor regulatory changes and ensure internal implementation.

Requirements

3 to 5 years of experience in regulatory affairs for medical devices;
Proven experience in certification processes (e.g. CE marking under MDR);
Solid knowledge of quality management systems (e.g. ISO 13485);
Experience in preparing technical documentation (Technical File / Design Dossier);
Ability to work both independently and within a multidisciplinary team;
Fluency in Portuguese and English (mandatory).

knokcare

Open Positions (1)

Management

Regulatory Affairs Specialist – Medical Devices