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, takin

📌 RA&QA (España)
🏢 EMPRESA ANONIMA
📍 España