Regulatory Affairs Manager

Idoven is on a mission to prevent heart disease with AI-powered cardiology. With our breakthrough technology to analyze the heart, we help find patients in need of treatment, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly and safely.

This is a unique opportunity. With the backing of top-tier global investors, including Insight Partners, Northzone and the European Commision (EIC and Horizon H2020), you'll have the responsibility and resources to shape the creation of a game-changing product that can save millions of lives.

Idoven has been honored with numerous awards, including recognition from UCSF as one of the the best new health applications of AI, CB Insight’s top 150 in digital health, the European Seal of Excellence, Best Startup at MEDICA (world’s largest medical event), Most Disruptive Startup and Best Health Startup at South Summit, and the Healthy Longevity Catalyst Award from the U.S. National Academy of Medicine.

About you

What you will do

• Prepare and coordinate regulatory submissions (technical files, design dossiers), report and correspondences for FDA 510(k) approval and CE certification and other regulatory agencies
• Collaborate closely with Quality, R&D and management to develop regulatory strategies which accelerate time to market and maximize product value
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
• Formulate and implement Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Serve as the primary company contact to and develop effective partnership with the FDA, EU notified body and other regulatory authorities
• Proactively identify regulatory risks to company's programs and develop risk mitigation plans
• Keep up to date on regulatory trends and guidances, and keep company apprised of expected changes to the regulatory landscape affecting existing and future regulatory policies, regulations, and standards
• Provide training, and interpretation of regulatory guidelines or issues to personnel

Requirements

• 5+ years of experience in Regulatory Affairs software-as-a-medical-device AI/ML.
• Technical file authoring experience (CE mark, FDA 510(K) and PMA).
• Hands-on experience in co-ordinating successful regulatory submissions for class II medical devices in Europe and US (class III and other jurisdictions is a plus).
• Experience working in startup environment, and/or building technical dossiers from scratch is important
• Working knowledge of (EU) MDD/MDR, 21 CFR part 11 and part 820 regulations (experience working under the MDSAP program is a plus).
• Strong knowledge of ISO 13485, ISO 14971, ISO 15223, IEC 60601, IEC 62304, and IEC 62366 (a huge plus if complementary knowledge in ISO 27001/17/18/701)
• Excellent organisation skills, attention to detail and ability to work on several simultaneous projects with tight timelines.
• Excellent verbal and written communication skills, including the ability to explain and train regulation to non-experts, techs, clinicians and business leaders.
• Excellent level of English, both written and spoken (Spanish and a third language is highly appreciated).
• Nice but not mandatory: RAPS certification (Regulatory Affairs Professionals Society).

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
🙋 Flexible remote working environment, where you can choose to work from home and come to our Madrid office whenever you want to
💸 Flexible Remuneration. We give you the flexibility to consume your benefits (from meals, transportation, kindergarten, training, and health insurance) directly from your payroll and receive tax benefits
😎 Regular team events and Thursday happy hours

And much more!