Regulatory Affairs Professional

8 hours ago


Belfast, United Kingdom ARC Regulatory Ltd Full time
Main Responsibilities
Support the work of the company and project teams in the provision of specialised regulatory expertise to client companies, ensuring that internal procedures and client expectations and interests are met. Bring considerable experience in IVD/CDx development, validation and approval to client organisations, providing expert strategies and guidance to their development programmes.
Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.
Conduct gap analyses on behalf of client companies and prepare associated reports (e.g. technical documentation/design history files). Contribute to the preparation of global guidance documents and white papers. Contribute to the preparation of other regulatory documents on behalf of client companies (e.g., Performance Evaluation Plans/Reports, Investigator Brochures, etc).



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