InnHealthium is a consultancy company that was born with the mission to help innovators transform healthcare.
Through our
360º consulting approach, we support healthcare companies across the entire journey, from technology discovery and product ideation to product development, compliance, market readiness and scale.
We are looking for a key hire to lead Regulatory Affairs and Quality Assurance projects for Medical Device and IVD companies, while contributing to the growth and development of InnHealthium.
This is a full-time, on-site position in Barcelona.
Role DescriptionThe role involves collaborating with internal teams and client stakeholders to plan regulatory strategies, identify gaps in documentation or processes. This role is for an experienced consultant who understands the technical, regulatory and strategic dimensions of healthcare innovation and can work directly with clients at different stages of maturity.
You will lead the implementation and maintenance of Quality Management Systems adapted to each client’s organisation, product and development stage.
You will also define and lead regulatory activities before and after market launch, including CE marking under MDR or IVDR and FDA pathways such as Pre-Submissions, 510(k), De Novo or other applicable routes.
Beyond RA/QA, you will contribute to multidisciplinary projects involving product development, project management, digital health, strategic market analysis and market readiness, working within InnHealthium’s 360º consulting model.
Train and mentor early stage innovator teams
Help optimize product development workflows, participate in audits and inspections, and provide clear, structured guidance to clients aiming to enter or expand in target markets.
Qualifications
Demonstrable experience leading Regulatory Affairs and Quality Assurance projects in Medical Devices or IVD.




At least 2–3 years of experience in similar consulting position. Or +5 RA/QA in industry.
Strong knowledge of MDR, IVDR, ISO 13485 and FDA regulatory requirements.
Experience implementing and maintaining QMS according to the client’s stage of maturity and market ((e.G., ISO 13485, ISO 14971),
Experience leading pre-market and post-market regulatory activities for CE marking and FDA clearance or authorization.Solid MedTech industry experience and understanding of product development.
Strong analytical, problem-solving and project management skills.
Ability to work autonomously and manage direct client relationships.
Master’s degree or higher in engineering, life sciences or a related field.
Professional fluency in English and Spanish.
MUST be Based in Barcelona or near by and available for hybrid work.
Excellent written and verbal communication skills in English;
proficiency in Spanish,Catalan is a plus.
Ability to work collaboratively on-site with multidisciplinary teams and client stakeholders, managing multiple projects and deadlines in a structured manner.
Experience in Digital Health, Software as a Medical Device, AI-enabled medical technologies or IVD would be particularly valued.
An understanding of strategic market analysis, market access principles and the language used by commercial, clinical and reimbursement stakeholders would be considered a strong plus.
What we offer
A key role in the growth of InnHealthium and its RA/QA practice.
The opportunity to contribute to InnHealthium’s 360º consulting model and help define how we support clients across the full innovation journey.
Direct involvement in innovative Medical Device, IVD and Digital Health projects.
A high level of autonomy, responsibility and client exposure.
Hybrid work based in Barcelona.
The opportunity to work closely with innovators developing technologies with real healthcare impact.
#J-18808-Ljbffr

📌 Medical Devices & Ivd Consultant Ra/Qa (Madrid)
🏢 InnHealthium
📍 Madrid