Clinical Affairs Manager (MedTech SaaS)
hace 5 días
Vitoria-Gasteiz
[Last day to apply: Sunday, September 20] About us 🩺 Legit.Health deploys computer vision and artificial intelligence medical devices to enable lifesaving diagnosis and therapies for visible diseases. Our goal is to enable universal access to high-quality diagnosis and follow-up of pathologies and to offer affordable health assistance to everyone everywhere. We are transforming how healthcare professionals diagnose and follow up visible diseases with cutting-edge AI. We already work with top hospitals and public health systems, we are scaling our clinical evidence team to ensure every client succeeds. Things you should know before following and signing up for the position: We are a startup, it is important that you are knowledgeable about how startups operate and know that at this stage there are more unknowns than certainties. There are many things to discover and define yet, so you will be part of that definition, therefore you will have many functions helping management. At Legit.Health we have a friendly open collaborative culture and a united team vision. We love entrepreneurial/risk taking/high ambition mindsets. Our work is rewarding and we help each other win by creating a supportive and collaborative environment for one another. Take a look at our opening below and send us your application - we look forward to hearing from you! Job description 🧑💻 We are looking for a Clinical Affairs Manager who can own our clinical evaluation and regulatory documentation end-to-end, with full technical and scientific confidence. You will not be a coordinator between teams. You will be the expert in the room: the person who designs and defends our clinical evidence strategy, leads our clinical documentation for both markets in which we are present and new markets. You will work closely with our Quality and Regulatory and Product Development teams, but you will not depend on them to lead clinical conversations. Your day-to-day will involve authoring Clinical Evaluation Plans and Reports, managing post-market clinical follow-up, and building the clinical evidence base that supports both European and FDA submissions. What you need to achieve 💪🏻 • Design and implement Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in full compliance with regulatory requirements of multiple geographies, including EU and US., • Lead the clinical audit processes with notified bodies and regulatory authorities during certification and approval processes., • Find, interact with and coordinate a network of consultants and experts to gather specialised insights and solve complex questions., • Design and monitor the budget for the clinical evidence department, including forecasting expenditure in clinical research and consultants., • Manage clinical data and results, ensuring traceability and scientific rigor throughout., • Author Statistical Analysis Plans (SAP) and Statistical Analysis Reports (SAR)., • Design and execute Post-Market Clinical Follow-Up (PMCF) plans and reports., • Conduct and coordinate systematic scientific literature reviews with methodological discipline., • Manage periodic updates and change control for CER and PMCF documentation., • Prepare and structure clinical dossiers for regulatory submissions, including FDA 510(k) applications., • Design clinical evidence strategies that comply with multiple regulatory frameworks, including EU (MDR) and US (FDA), avoiding duplication and ensuring consistency across submissions., • Translate clinical evidence into clear, actionable insights for Product and Medical Science teams., • Identify gaps in clinical data early and propose structured approaches to address them. Must have 🔍 • Degree in Medicine, Pharmacy, Biology, Biomedical Engineering, or equivalent., • GCP certification required., • RAPS (Regulatory Affairs Certification) required or actively in progress., • Master's in Regulatory Affairs is strongly recommended., • Experience: 5+ years in clinical trials, regulatory affairs, or medical writing within the medical device industry. We will consider equivalent demonstrated seniority outside this exact profile., • Regulatory depth: Demonstrated hands-on experience with MDR and/or FDA regulatory frameworks. You know what a submission-ready CER looks like and you can build one., • GCP and quality standards: Solid knowledge of Good Clinical Practice (GCP) and ISO 13485., • Software and AI device experience: Direct experience working with software as a medical device (SaMD) or AI-based medical devices., • Scientific rigor: Strong command of clinical literature review, clinical data analysis, and basic statistics. You can design a SAP, not just read one., • Tools: Proficiency with EUDAMED, scientific databases (PubMed, Cochrane), and regulatory documentation software., • Autonomous execution: You manage complex, multi-stakeholder documentation projects independently. You keep your own context, set your own priorities, and deliver without being asked twice., • Languages: High proficiency English (written and spoken). Strongly preferred (differentiators) • Familiarity with agentic coding tools (Claude Code or similar) and version control platforms (GitHub) for documentation workflows and regulatory automation., • Direct experience with AI-based or image analysis SaMD., • Familiarity with the clinical areas where we operate: dermatology, oncology and wound care., • Experience supporting both EU and US submissions in parallel. Nice to have 🌟 • Able to work autonomously, with discipline and with high motivation and energy., • Proactive, willing to learn, have an impact and grow in the company., • Team player capable of adapting to changes in a fast-paced environment., • Comfortable working in a fully remote, async-first environment. What do we offer ☺️🏝️ • Full-remote position. We are a team of committed professionals, so you choose where you work from and also means that all processes need to be thought of as if we had no office and everyone is working remotely. No one will feel like an outsider, since all conversation will need to happen on Slack or hangouts., • Working in a fast growing Start-up environment within an international context. You’ll join at a key moment to make a huge impact on how we scale with hospitals, public health systems or pharmaceutical companies., • Flexible compensation: daycare and restaurant., • Flexible vacation policy: 23 working days per year + 2 additional days granted by the company (your anniversary and December 7th) + 2 days for company closure per labor agreement (December 24th and 31st)., • Flexible working hours., • Permanent contract., • Competitive salary according to your experience. In compliance with the provisions of the data protection regulations, we inform you that the personal data you have provided with your resume will be processed in a mixed manner (automated or not) by AI Labs Group, S.L., with NIF B95988127 and address in Gran Vía, 1, BAT Tower, Bilbao (Bizkaia), 48001 (hereinafter, Legit.Health). The purpose of this data processing is the management of Legit.Health's personnel selection processes and is based on your prior consent. Your data will be kept for one year, after which we will proceed to cancel it. You are also informed that no automated decisions will be made. Your data will not be transferred to third parties. At any time you can exercise your rights of access, rectification, deletion, portability, limitation, or opposition, by writing to the email legal@legit.health. We also inform you that you can go to the Control Authority to assert your data protection rights. *Please note that this is not an email to submit job applications. We are only processing the data you have provided for specific personnel selection processes. If you wish to apply for a position, please follow the instructions on our official job postings. Sincerely, Legit.Health team.
Ana F.Activo hace 11 horas
