Clinical Affairs Manager; MedTech SaaS

Puesto: Clinical Affairs Manager (MedTech SaaS)
Location: Chazo

[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.
lth 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…