Open to opportunities

Diamela Rocca

@diamelarocca

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I develop regulatory documentation and clinical evidence for implantable medical devices.

Argentina

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What I'm looking for

I'm looking to apply my regulatory, clinical, and scientific research background to medical-device work involving product compliance, clinical evidence, quality systems, and post-market surveillance.

At Promedon S.A., I develop regulatory and clinical documentation for implantable medical devices, including MDR 2017/745 reviews, product files, ISO gap analyses, clinical evaluation reports, and post-market surveillance reports.

I'm a pharmacist and Doctor of Chemical Sciences from the National University of Córdoba. My doctoral research focused on antimicrobial compounds for clinically relevant bacteria, resulting in peer-reviewed publications on antibacterial nanoparticles, biofilms, and medical-device coatings, as well as a patent application for anti-fouling polymeric surface coatings. I also bring experience in pharmaceutical care and university teaching in pharmaceutical analysis, microbiology, and botany.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs Analyst

Current

Promedon S.A.

Feb 2021 - Present (5 years 6 months)

Analyst of regulatory aspects and clinical affairs. Studied European medical device regulation (EU) 2017/745 (MDR), developed quality procedures, prepared product files for implantable medical devices, performed GAP analysis of ISO standards, and prepared clinical evaluation and post-market surveillance reports.

Regulatory Affairs Medical Devices MDR ISO Standards Clinical Evaluation Post Market Surveillance