Descripción de la oferta
Sunday, September 20]
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.
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.
Health we have a friendly open collaborative culture and a united team vision. 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 work closely with our Quality and Regulatory and Product Development teams, but you will not depend on them to lead clinical conversations. 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).
Manage periodic updates and change control for CER and PMCF documentation.
Identify gaps in clinical data early and propose structured approaches to address them.
Degree in Medicine, Pharmacy, Biology, Biomedical Engineering, or equivalent.
Experience: 5+ years in clinical trials, regulatory affairs, or medical writing within the medical device industry. GCP and quality standards: Software and AI device experience: Direct experience working with software as a medical device (SaMD) or AI-based medical devices.
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.
You manage complex, multi-stakeholder documentation projects independently. Languages: High proficiency English (written and spoken).
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.
Comfortable working in a fully remote, async-first environment.
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.
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.
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.
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. Your data will not be transferred to third parties. We also inform you that you can go to the Control Authority to assert your data protection rights.
*We are only processing the data you have provided for specific personnel selection processes. Health team.
