Regulatory Affairs Specialist

15 hours ago


Belfast, United Kingdom ARC Regulatory Ltd Full time
Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at ARC Regulatory Ltd. As a Senior Specialist- Regulatory Affairs, you will be responsible for delivering global compliance solutions to client companies.

You will utilise your expertise in IVD/CDx development, validation and approval to provide expert strategies and guidance to client development programmes. Your responsibilities will include researching and preparing regulatory submission documents, conducting gap analyses, and managing information related to global regulatory requirements for IVD devices.

In this role, you will have the opportunity to work with a dedicated team of experts who possess unparalleled domain knowledge and have developed important relationships with global clients. You will also contribute to the preparation of global guidance documents and white papers, as well as other regulatory documents on behalf of client companies.



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