$200K — $250K *
You are a medical software regulatory guru, with previous work experience in FDA, plus at least 10 years of first-hand experience in obtaining SaMD regulatory clearance.
You will own and maintain Darmiyan’s QMS system and will guide the organization for proper regulatory compliance.
You will prepare and direct FDA presub and submission packages and lead Darmiyan’s meetings with the agency.
You will also guide Darmiyan’s navigation of international regulatory pathways, and ascertain organizational compliance with other regulatory requirements such as HIPAA.
Valid through: 12/9/2020