Hybrid Regulatory Affairs Specialist – Medical Devices

at knokcare

• Job title: Regulatory Affairs Specialist – Medical Devices
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Matosinhos, Portugal

About the role

• Regulatory Affairs Specialist managing regulatory processes and ensuring compliance for medical devices. Focusing on EU regulations and collaborating with multidisciplinary teams for certification and quality management.

Responsibilities

• 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).