RA&QA

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

We are supporting a fast-growing Medical Devices company that is developing innovative solutions. As the company continues to grow internationally, we are looking for a QA/RA Manager to take ownership of the Quality & Regulatory Affairs function and support the business in its next stage of expansion.

WHAT WILL YOU DO?

You will be the main point of contact for Quality & Regulatory Affairs, working closely with the CEO and collaborating with Product, R&D, Clinical, Marketing and Business teams.

Your responsibilities will include:

• Lead and maintain the ISO 13485 Quality Management System
• Ensure compliance with EU MDR 2017/745 and applicable medical device regulations
• Manage Technical Documentation, regulatory changes and product compliance
• Lead PMS, vigilance, risk management, CAPA, non-conformities and change control
• Coordinate audits and interactions with Notified Bodies and regulatory authorities
• Support regulatory requirements for international market expansion
• Advise Product and R&D teams on regulatory implications of new features and product changes
• Review marketing claims and commercial materials from a regulatory perspective
• Support the company in navigating the regulatory requirements associated with software and AI

WHAT WE ARE LOOKING FOR?

5+ years of experience in QA/RA within Medical Devices, SaMD, Digital Health or a 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 working with Medical Device Software / SaMD is highly valued
• Experience with Notified Bodies and audits
• Professional English and Fluent Spanish
• High level of autonomy, ownership and attention to detail
• Ability to work cross-functionally and translate regulatory requirements into practical business solutions

Nice to have:

IEC 62304, IEC 62366-1, GDPR, ISO 2701/ENS and international regulatory experience.

WHY THIS ROLE?

You will join a high-growth MD company, taking ownership of a critical function at a key stage of international expansion.

• High level of autonomy and visibility
• Direct exposure to senior management
• Innovative Medical Device Software environment
• International growth
• Hybrid working model in Barcelona
• Real opportunity to shape the QA/RA function

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