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 27001/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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📌 RA&QA (Barcelona)
🏢 EMPRESA ANONIMA
📍 Barcelona