Regulatory Affairs Associate
A bilingual Pharmacy graduate advancing his expertise with a Master's in Preclinical and Clinical Drug Development. Possesses robust knowledge of EU and FDA regulatory frameworks (MDR, IVDR, 21 CFR) for medicines, medical devices, and IVDs. Experienced in supporting international compliance activities, including CE marking, technical file compilation, post-market surveillance (PMS/PMCF), and pharm...
Experience: 2+ years
Joel Akoto provides regulatory consulting services to clients in:
Possesses a strong academic foundation with a Master's degree in Pharmacy from the University of Rome Tor Vergata, complemented by a current second Master's in Preclinical and Clinical Drug Development from Università Cattolica del Sacro Cuore. This unique combination provides a comprehensive understanding of the entire product lifecycle, from scientific development to regulatory approval and post-market safety. This dual expertise in both pharmaceutical science and regulatory affairs makes them a valuable asset for medtech companies navigating complex compliance landscapes.
Demonstrates a strong career trajectory with hands-on regulatory experience at leading global companies, including Johnson & Johnson Medtech and Perrigo. They have directly contributed to critical compliance projects, such as integrating medical devices into the EUDAMED system and supporting CE marking for IVDs and medical devices. Their experience includes compiling and maintaining technical files, coordinating with Notified Bodies, and managing post-market surveillance and pharmacovigilance activities. This background in both large medtech and multinational pharmaceutical environments showcases their adaptability and deep understanding of EU regulatory requirements.
A bilingual Pharmacy graduate advancing his expertise with a Master's in Preclinical and Clinical Drug Development. Possesses robust knowledge of EU and FDA regulatory frameworks (MDR, IVDR, 21 CFR) for medicines, medical devices, and IVDs. Experienced in supporting international compliance activiti...
Joel Akoto brings a powerful combination of a strong pharmaceutical academic background and hands-on regulatory experience from a global leader, Johnson & Johnson Medtech. With 2 years of focused experience, he possesses highly current and practical expertise in the complex EU MDR and IVDR frameworks, a critical need for any company operating in Europe. His proven skills in compiling technical files, managing post-market surveillance, and supporting clinical trial compliance (GCP, ISO 14155) demonstrate his ability to manage the product lifecycle effectively. This unique blend of big medtech experience and up-to-date knowledge of EU/FDA regulations makes him an exceptionally valuable asset for companies needing to ensure compliance for IVDs, medical devices, and combination products.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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