MedTech QA/RA Manager — Lead Quality & Regulatory

Empresa Anônima; Barcelona; Híbrido; EUR 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model in Barcelona

Exposure to senior management

Descripción de la vacante

Empresa Anônima is seeking a QA/RA Manager to own the Quality & Regulatory Affairs function as the company expands internationally. You will work directly with the CEO and collaborate with Product, R&D, Clinical, Marketing and Business teams from Barcelona in a hybrid setup.

The role requires 5+ years in QA/RA for Medical Devices or SaMD, strong MDR/ISO knowledge, and the ability to translate regulatory needs into practical solutions across software and AI initiatives.

Formación

• 5+ years of QA/RA in Medical Devices, SaMD, Digital Health or similar regulated environment
• Strong knowledge of MDR 2017/745, ISO 13485 and ISO 14971
• Experience with QMS, PMS, risk management, CAPA and technical documentation
• Experience with Notified Bodies and audits
• Professional English and Fluent Spanish
• High level of autonomy, ownership and attention to detail
• Ability to translate regulatory requirements into practical business solutions

Responsabilidades

• Lead Quality & Regulatory Affairs, liaising with CEO and cross-functional teams
• Maintain ISO 13485 Quality Management System
• Ensure compliance with EU MDR 2017/745 and medical device regulations
• Manage Technical Documentation, regulatory changes and product compliance
• Lead PMS, vigilance, risk management, CAPA, non-conformities and change control
• Coordinate audits with Notified Bodies and authorities
• Support regulatory requirements for international market expansion
• Advise on regulatory implications of new features and product changes
• Review marketing claims from a regulatory perspective
• Navigate regulatory requirements for software and AI

Conocimientos

QA/RA management

MDR 2017/745

ISO 13485

ISO 14971

QMS

PMS

CAPA

Notified Bodies audits

Medical Device Software SaMD

English

Spanish

Descripción del empleo

Empresa Anônima is seeking a QA/RA Manager to own the Quality & Regulatory Affairs function as the company expands internationally. You will work directly with the CEO and collaborate with Product, R&D, Clinical, Marketing and Business teams from Barcelona in a hybrid setup.

The role requires 5+ years in QA/RA for Medical Devices or SaMD, strong MDR/ISO knowledge, and the ability to translate regulatory needs into practical solutions across software and AI initiatives.