Aortyx is looking for Jr. and Sr. Regulatory Affairs Specialists (m/f) to work full-time, on-site, in Esplugues de Llobregat, Barcelona.

Main tasks and responsibilities

- Assist on the development and implantation of the Regulatory Roadmap.
- Update the risk analysis matrix and the bench testing derived from it.
- Define the bench testing and biocompatibility studies priorities as a function of the development of Aortyx’ products.
- Educate and guide the R&D; team.
- Interact with Regulatory Affairs consultants.
- Interact with external testing laboratories.
- Interact with the FDA and with European Notified Bodies.

This ole involves preparing, reviewing, and maintaining regulatory documentation to support product development, approvals, and lifecycle management of Aortyx' products. The specialist will monitor evolving regulatory requirements, interpret their impact on Aortyx’s products, and collaborate with cross-functional teams (R&D;, Quality, Clinical) to ensure regulatory compliance throughout the product lifecycle. Additional responsibilities include supporting audits and inspections, maintaining internal regulatory procedures, and contributing to risk management and product labeling activities.

Qualifications

EDUCATION

- Bachelor's degree in life sciences, engineering,



or a related field.
- Advanced degree (e.g., Master's, PhD) is preferred.

SKILLS

- Knowledge of medical device regulations (EU MDR, FDA CFR 21 Subchapter H, ISO 10993) and risk management (ISO 14971).
- Strong skills in preparing and managing Regulatory Documentation, including technical files and supporting evidence.
- Demonstrated experience in Regulatory Compliance, ensuring adherence to applicable standards and guidelines.
- Ability to interpret and apply Regulatory Requirements from EU MDR and/or the FDA.
- Experience coordinating and submitting Regulatory Submissions to authorities, notified bodies, or ethics committees.
- Background in Regulatory Affairs, working closely with cross-functional teams in a medical device or healthcare environment.
- Effective collaboration skills for working with engineering, quality, and clinical teams.
- Strong analytical and organizational skills, including the ability to prioritize tasks, meet deadlines, and manage multiple projects in a fast-paced environment.
- Excellent communication and interpersonal skills.
- Analytical thinking and problem-solving abilities.
- Fluent Spanish and Professional English (C1) are required.

📌 Regulatory Affairs Specialist (Barcelona)
🏢 Aortyx
📍 Barcelona