Hybrid Regulatory Affairs Manager – Conformity and Technical Manager

at Mediphacos

• Job title: Regulatory Affairs Manager – Conformity and Technical Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Portugal

About the role

• Manage the certification processes for medical devices, ensuring compliance with EU regulations and supporting internal teams on regulatory issues. Requires expertise in engineering and medical device certification.

Responsibilities

• Manage the technical aspects and coordinate the CE certification process for medical devices in accordance with Regulation (EU) 2017/745 (MDR);
• Support the preparation and review of technical files and compliance documentation;
• Liaise with notified bodies, competent authorities and external partners;
• Ensure implementation and maintenance of the quality management system (ISO 13485);
• Serve as Technical Responsible (Responsible Person) to INFARMED and other regulatory authorities;
• Support internal teams (R&D, Production, Marketing) on regulatory and quality matters.

Requirements

• University degree in Biomedical Engineering, Pharmaceutical Sciences, Biotechnology or a related field;
• Proven experience (min. 3 years) in CE marking processes for class IIa, IIb or III devices;
• Solid knowledge of the MDR (2017/745) and ISO 13485;
• Experience in the ophthalmology market is a plus;
• Project management and planning skills, with experience liaising with external entities;
• Fluency in Portuguese and English (written and spoken);
• Strong sense of responsibility, attention to detail and ability to work autonomously.