AirSep Corporation

-Ensure compliance ISO 13485, ISO 9001, FDA QSR, MDD, PED, MDSAP, etc. -Assist/review / implementation of internal regulatory procedures to regulatory compliance to maintained or enhanced -Assist with internal training regarding regulatory and associated reporting requirements. -Management review meetings & quality objectives -AirSep Quality Management Representative -Internal and external audits -Product approvals including document submissions to regulatory authorities notified bodies.