Bachelor's degree in relevant field (or equivalent experience, i.e.

Associates Degree with 3 years of experience)
A minimum of 2 years of experience in a regulated industry, preferably medical device.

Software and/or software as a medical device experience a plus.
Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
Knowledge of the General Data Protection Regulation (GDPR), ISO 27001, and HIPAA.

Knowledge of SOC 2 a plus.
Experience with Regulatory Agency audits a plus
Excellent written and oral communication skills