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Senior Regulatory Affairs Specialist

Cordis • Irvine, CA, US • published 2026-10-06 07:33:52.841073

Description

Overview: Selution, in partnership with Cordis, specializes in the development of ground\-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next\-generation solutions that address unmet and critical medical needs. Responsibilities: The Senior Regulatory Affairs Specialist will assist, lead and author documentation to support high\-quality regulatory submissions. They will work closely with engineers, quality assurance, clinical and other technical experts to develop strategies to ensure compliance to regulations and to assist in responding to questions from regulatory authorities. **Key Responsibilities** * Prepare and manage global regulatory submissions (EU MDR, FDA IDE/PMA, LATAM, APAC). * Advise on regulatory strategies for development and marketed products. * Lead process improvement initiatives to increase regulatory efficiency. * Ensure ongoing compliance with QSR, ISO, and MDSAP requirements. * Act as a regulatory representative on large projects/programs to provide regulatory strategy and planning in line with Product Deve...

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