Senior Regulatory Affairs Specialist

Why Merit?
En Merit Medical, nuestra misión es desarrollar dispositivos médicos innovadores que mejoren vidas.
Nuestro objetivo es integrar y desarrollar a gente que quiere construir a través de trabajo duro, en equipo y comprometido, dispositivos que salvan vidas.
Juntos estamos haciendo la diferencia en la vida de pacientes de todo el mundo.
ESSENTIAL FUNCTIONS PERFORMED
1. Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
2. Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
3. Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
4. Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities.
5. Prepares IDEs and PMAs and assists with clinical trials whe...