QA & Regulatory

• Professional growth towards a Head of QA & RA role.
• Autonomy, trust, and strategic vision.
• Close work with product and technology.
• Agile environment, oriented towards real impact.
• Hybrid model and flexible hours.
• Close-knit team, with a high technical and human level.
• 22 days of vacation + day off for your birthday.
• Promotions and discounts on various brands.

• 5+ years of experience in QA / Regulatory Affairs in digital medical products.
• Demonstrable experience implementing ISO 13485.
• Real experience in CE marking under MDR.
• Direct participation in certification processes.
• Residency or availability to work in Valencia or Madrid (hybrid model).

- SaMD (Software as a Medical Device).

- MDR (EU 2017/745).

- ISO 13485.

- IEC 62304.

- ISO 14971.

- IEC 62366.

• Experience with AI products / algorithms.
• Having built quality systems from scratch.
• Experience in startup or scaleup environments.
• Direct management with notified bodies.

Can you imagine leading the quality and regulation of an AI product used in hospitals that improves healthcare?

At Omniloy, we are not just creating another piece of software.

We are looking for a QA & Regulatory (Quality Assurance & Regulatory) with prospects of becoming Head of QA & Regulatory Affairs to lead the quality and regulation strategy for an AI-based Software as a Medical Device (SaMD).

This role will be responsible for building the area from scratch, defining the Quality Management System under ISO 13485, leading the CE marking process in accordance with the MDR, and establishing the regulatory foundations to scale the product at a European level.

Regulatory Affairs (RA) encompasses defining the regulatory strategy, managing relationships with notified bodies, and obtaining and maintaining the certifications necessary for the commercialization of the medical device.

You will join a team where quality and regulation are part of the product from the design stage, not as a final addition. Some of your responsibilities will be:

• Building and implementing the Quality Management System (QMS) under ISO 13485 end-to-end.
• Defining and executing the regulatory strategy for an AI-based SaMD.
• Leading the CE marking process in accordance with the MDR (EU 2017/745).
• Preparing the organization for internal and external audits and certification processes.
• Preparing and maintaining the technical documentation of the product.

You will work in areas such as:

- Clinical Evaluation

- Risk Management (ISO 14971)

- Usability Engineering (IEC 62366)

- Software Lifecycle (IEC 62304)

- Design Control and integration of compliance into product development.

Additionally, the role has a strategic and transversal component that includes:

- Direct communication with the notified body.

- Close collaboration with engineering, data, product, and clinical teams to ensure compliance by design.

- Defining the regulatory foundations for the European scaling of the product.

Progressively evolving the role towards Head of QA & RA, leading the area autonomously.