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