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 w

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