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 Description

The 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

📌 Medical Devices (Barcelona)
🏢 InnHealthium
📍 Barcelona