Product Manager

About UsIdoven 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.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: As the Product Manager (SaMD), you will:Product Strategy & Vision: Define and drive the product vision and roadmap for Idoven's SaMD portfolio, ensuring alignment with business goals, regulatory requirements, and user needsRegulatory & Compliance Leadership: Collaborate closely with Quality, Regulatory Affairs, and Clinical teams to ensure compliance with MDR, FDA, ISO 13485, and IEC 62304 standards throughout the product lifecycleCross-Functional Collaboration: Work with engineering, data science, clinical, and design teams to translate clinical and user insights into safe, effective, and market-leading SaMD productsProduct Lifecycle Management: Oversee the end-to-end product lifecycle - from concept, development, verification, and validation to market launch and post-market surveillanceStakeholder Management: Gather and prioritize requirements from internal and external stakeholders, including clinicians, patients, and regulatory partners, to ensure our products deliver clinical and commercial valueEvidence Generation & Market Insight: Collaborate with Clinical and Marketing teams to define evidence-generation strategies, analyze real-world performance, and inform product enhancementsAI/ML Product Stewardship: Collaborate with data science and AI teams to ensure AI/ML algorithms meet requirements for transparency, validation, and performance monitoringContinuous Improvement: Stay up to date on evolving SaMD regulatory frameworks, digital health trends, and AI/ML validation practices, driving continuous product and process improvementRequirementsWhat You Need to Succeed5+ years of experience as a Product Manager, with at least 3 years focused in digital health, medtech, or regulated software environments, preferably in API-based backend productsProven experience managing SaMD products through a full lifecycle - from concept to post-market - with at least 1 successful certified product launchSolid understanding of MDR, FDA (21 CFR 820), ISO 13485, ISO 14971, and IEC 62304 standardsExperience with clinical validation, usability engineering, and risk management for medical softwareStrong technical acumen with the ability to work closely with AI, data, and engineering teamsExcellent project management and cross-functional collaboration skillsStrong communication skills, capable of interfacing with technical and clinical stakeholdersFluency in English and Spanish. Experience in cardiology, AI/ML algorithms and health integration protocols (HL7, FHIR, etc) is a strong plusBenefits🚀 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 hoursAnd 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.