About us 

Idoven is a European healthtech company using artificial intelligence to advance the early diagnosis of cardiovascular diseases, the leading cause of death worldwide.

Our CE-marked AI platform, Willem, analyzes electrocardiograms (ECGs) from any device, helping doctors detect heart conditions faster, more accurately and at scale.

Backed by the European Innovation Council, Horizon 2020, and top-tier investors, we’re building technology with the potential to save millions of lives.

We collaborate with leaders like AstraZeneca, Abbott and EIT Health, and our work has been recognized by the European Seal of Excellence, the U.S. National Academy of Medicine, CB insights' Digital Health Lists, and South Summit as Most Disruptive Startup.

Global icons Iker Casillas and Pau Gasol support our mission as brand ambassadors, helping raise awareness around heart health. We have created the first mobile app that allows people to donate their heartbeats — turning everyday signals into science with the purpose of preventing heart disease.

If you're looking to build technology with real-world impact at one of Europe’s most promising deep-tech companies, Idoven is the place to do it.

About the Role

The RAQA Specialist will play a key role in supporting the company’s regulatory strategy and quality system execution to ensure compliance with global medical device regulations. This role bridges regulatory and quality functions, contributing to the handling of technical documentation, regulatory submissions documentation, QMS maintenance activities, facilitating communication, and exchange of information between departments.

Regulatory Support

• Assist in the preparation, review, handling, and submission of regulatory documentation for global markets (e.g., EU MDR, FDA 510(k)).
• Maintain regulatory files within the eQMS and track submission timelines and approvals.
• Support updates to regulatory documentation, ensuring continuous compliance as products evolve.
• Help interpret regulatory requirements and communicate them across teams and departments.

Quality System Support

• Assist in maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR Part 820.
• Support internal audits, CAPA management, and documentation control processes.
• Coordinate the collection and presentation of documentation for internal and external audits.
• Ensure that quality and regulatory documentation (e.g., Technical Files, DHF, DMR) is up-to-date, accurate, and audit-ready.

Documentation & Compliance

• Prepare and review controlled documents, ensuring alignment with internal procedures and external regulations.
• Support the creation and maintenance of product technical documentation for CE marking and international submissions.

Cross-Functional Collaboration

• Work closely with Product, Engineering, Data R&D, and Clinical teams to ensure regulatory and quality requirements are integrated throughout product development and lifecycle.
• Support communication with external partners, auditors, and regulatory authorities when required.

Requirements

Required Qualifications:

• Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Life Sciences, Quality, Regulatory Affairs) - Master's degree a plus
• Min. 3 years of experience in regulatory affairs or quality assurance roles, preferably within the medical device or healthcare technology industry.
• Demonstrated experience with Medical Device QMS documentation for the EU MDR (mandatory) and the US FDA (21 CFR).
• Familiarity with ISO 13485 and quality system documentation.
• Strong organizational and documentation management skills with high attention to detail.
• Excellent communication skills, both written and verbal, in English (Spanish is a plus).
• Ability to work collaboratively in a cross-functional, fast-paced startup environment.
• Ability to translate complex technical concepts and quality requirements to the intended audience in a clear and understandable way.
• Proactive and self-motivated with a continuous learning mindset.
• Ability to collaborate and communicate effectively in a flat-hierarchy.
• In-depth attention to detail and accuracy with the ability to prioritize and work on multiple projects in a fast-paced, start-up environment.

Nice to Have

• Previous exposure to audit preparation or regulatory inspections.
• Familiarity with the regulatory submission process (e.g., FDA 510(k), CE mark documentation) is a plus.
• Experience with Software as a Medical Device.
• Experience navigating a regulated industry environment and AI software development standards and regulations (EU AI Act, ISO 42001…) is a plus.
• Experience with Information Security related standards and regulations (ISO 27001)

Desired Qualifications:

• Basic understanding of regulatory affairs for medical devices is a plus.
• Familiarity with the regulatory submission process (e.g., FDA 510(k), CE mark documentation) is a plus.
• Experience navigating a regulated industry environment is a plus.

Benefits

🚀 Be part of one of the most disruptive startups in HealthTech and AI and make a difference

🏆 Personal and professional growth as part of a fast-growing, international team

🎧No corners cut in having the best tech equipment to do your job

🙋 Unlimited remote working environment, where you can choose to work from home and attend our Madrid office whenever you want to

📚Learning and development opportunities and training budget

💸 Flexible Remuneration

👩🏻‍⚕️ Health Insurance provided by IDOVEN

🏋 Access to Wellhub (Gympass), empowering your physical and mental wellness!

🖥️ Remote Work Allowance for your home office setup!

🌴 23 holidays, your birthday off, and December 24th and 31st half days to celebrate!

😎 Regular team events and Thursday happy hours

And much more!

At IDOVEN, we believe in hiring top talented people like you - ambitious, forward thinkers who want to make a difference in the world and have an impact.

Diversity & Inclusion 

At Idoven, we believe diverse teams build better products. We are an equal opportunity employer and welcome applicants from all backgrounds, regardless of race, gender identity, age, religion, sexual orientation, or disability.