1MED SA
Rachel King has extensive experience in regulatory affairs within the medical device industry. Rachel has held various roles such as Regulatory Affairs Manager, Senior Regulatory Specialist, Regulatory Affairs Associate, and Regulatory Affairs Technician. In these positions, Rachel has been responsible for tasks such as submission and maintenance of Design Dossiers and Technical Files for medical device registration in the EU and the USA, sterilization validation, packaging validation, writing and maintaining QMS documentation, and providing regulatory input to CAPA activities. Rachel's experience also includes quality assistance and maintenance of Technical Files for medical devices. Rachel holds a degree in Biomedical Science from Cardiff University.
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1MED SA
1MED, is the leading European MedTech specialized solutions provider, offering end-to-end development expertise within the medical device, novel technology and combination products fields. Founded in 2014, with headquarter in Agno, Switzerland, and employing 100+ professionals across the Europe, 1MED's mission is to support all the MedTech organizations in facing the complexity associated with the development of innovative medical devices in compliance with MDR. Such support may include providing preclinical support, regulatory advice, clinical study management, post marketing support and quality management systems across the clinical research continuum with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices in the last 2 years only. 1MED not only offers a broad range of internal competences, our clients in fact can trust on a preferred partners network and consolidated relationships with European Notified Bodies and Competent Authorities. There is much more to know about us! Please visit https://www.1med.ch/ to learn about the solutions we can offer or e-mail us: info@1med.ch