Profile Summary
Javier S.
Medical physicist with 4 years of experience. MATLAB programmer and expert in statistics applied to health sciences.
Shaheen Fathima A.
Regulatory documentation either moves a program forward or it doesn't. I make sure it does. I'm a RAC-Drugs certified Regulatory Affai...
Dr. Sumit M.
I am a medical doctor (MBBS) and certified clinical researcher specialized in high-stakes regulatory documentation and clinical trial design. M...
Dr. Christoph P.
Most startups realize too late: getting a digital health product from concept to CE mark is as much a regulatory journey as a technical one. I...
Towanda L.
Regulatory Affairs: FDA submissions, EU MDR technical files, Post-Market Surveillance Reports (PSURs), and Declarations of Conformity. Quality...
Dr. Pedro D.
I am a foot and ankle orthopaedic surgeon and researcher based in Brussels, Belgium, with consultant appointments in university hospital practi...
Shellie K.
Manufacturers turn to me when their Notified Body has flagged a Clinical Evaluation Report, or when their clinical evidence strategy can't ...
Shivani A.
I am a Biotechnology professional with over 6 years of experience in clinical data management, regulatory documentation, scientific research, a...
Arnaud K.
Senior MedTech Professional with 8+ years of experience in high-stakes regulated industries, specializing in Class IIa/IIb medical devices. I b...
Dr. Raymond H.
Dr. Raymond Haddad, MD, MHSc, PhDc, FPICS, is a physician with over a decade of clinical, academic, and scientific experience. He is an accompl...
Deepak D.
Highly motivated Regulatory Affairs professional with strong expertise in U.S. FDA 510(k) submissions, Indian import licensing (CDSCO), ISO 134...
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Oliver S.
As a former Post-Market Surveillance & Vigilance Manager at Mathys (Swiss manufacturer of artificial joint implants), I have extensive hand...
Valentin G.
I am a Senior Data Scientist and biomedical AI specialist with 8+ years of experience developing machine-learning solutions for medical imaging...
Kamran V.
Expert in developing ISO 27001 Information Security, Penetration Testing, ISO 9001, ISO 14001, ISO 22000 Food Safety Management System, HACCP P...
Mélodie K.
Executive leader in Quality, Regulatory, and Transformation Strategy, enabling life sciences organizations to accelerate market access, reduce ...
Deepa K.
I’m a passionate **Biochemistry postgraduate** with over **10 years of hands-on experience in Research & Development**, driven by a deep cu...
Dr. Amin J.
Biomedical Engineer (PhD) specializing in Medical Devices, Regulatory Writing, and Clinical Evaluation. Experienced in preparing CER, MDR‑compl...
Dr. James T.
I am a neuroscience PhD and translational research professional helping biotech, medtech and life-science teams turn complex scientific, clinic...
David I.
I am a Medical Device Regulatory & Labeling Consultant and Founder of ATA Labeling Solutions LLC, specializing in global labeling complianc...
Patrik S.
I currently work as a Clinical Research Lead in a Neurotech startup specializing in movement-based therapy and fNIRS. My role encompasses clini...
Dishan O.
I am a Mechatronics Engineer with expertise in biomedical engineering, artificial intelligence, computer vision, embedded systems, and medical ...
Dr. Lalit Raj S.
# Dr. Lalit Raj Singh **Medical Devices, IVDs & Pharmaceutical Regulatory Affairs | EU MDR/IVDR | WHO Prequalification | Technical Document...
Yogesh B.
Dr. Yogesh S. Biradar (M.Pharm., Ph.D.) is a pharmaceutical scientist, medical writer, and regulatory consultant with more than 20 years of exp...
Pharma A.
Leading Pharma Assurance to provide specialized quality management and regulatory compliance solutions for pharmaceutical manufacturers and lif...
Dr. Diana K.
I’m a medical doctor (OB/GYN), bioinformatics & data science graduate, and experienced medical writer with 4+ years in clinical trial suppo...
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