The Regulatory and Clinical Affairs Director will lead regulatory and clinical strategy for Aortyx’s medical devices, ensuring compliance with applicable regulations and standards. This full-time, on-site role is based in Esplugues de Llobregat (Barcelona) and involves close collaboration with R&D; and Quaality teams. Day-to-day responsibilities include defining and implementing the regulatory strategy, preparing and overseeing regulatory submissions, driving interactions with regulatory authorities and notified bodies, and monitoring regulatory changes that impact product development and market access.

The director will also lead the design and execution of the clinical evaluation plan, ensure alignment between clinical evidence and regulatory requirements, and provide guidance to cross-functional teams throughout the product lifecycle.

Qualifications Strong expertise in Regulatory Requirements and Regulatory Affairs for Class III cardiovascular medical devices.



Demonstrated ability to design and implement Regulatory Strategy that supports product development and approval. Proven experience preparing, coordinating, and reviewing Regulatory Submissions for the USA and/or the EU.

Experience in clinical affairs, including clinical study design, execution, and clinical evaluation for medical devices. Deep knowledge of relevant standards and regulations (e.g., EU MDR, ISO 14155, ISO 13485) and regulatory authority expectations.

Skills Master’s or Ph D in a scientific, engineering, medical, or related field. Excellent analytical, writing, and documentation skills, with attention to detail and accuracy. Ability to work as part of a team, manage a small department, set priorities, and meet deadlines in a fast-paced environment. Professional proficiency in English is a must; conversational Spanish is strongly recommended. Previous leadership experience in regulatory or clinical affairs within the medical device industry.

📌 Regulatory and clinical affairs director (Madrid)
🏢 Aortyx
📍 Madrid