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

#Hiring #QA #RA #QualityAssurance #RegulatoryAffairs #MedicalDevices #SaMD #DigitalHealth #MedTech #Barcelona #HealthcareJobs #MedTechJobs

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