As the Regulatory Affairs Manager at Biomerics, a medical device contract manufacturer, Anita works in many aspects of product development. Besides writing and filing 510(k)s, Technical Files, and other regulatory submissions, Anita works closely with engineering teams on Design Input Requirements, Design Verification and Validation Protocols and Reports, Pilot Study DOEs, Risk Management activities, and marketing aspects of medical devices such as labels and labeling. Anita holds a Bachelor’s degree in Statistics with an Applied Emphasis, and minors in Mathematics and Business. She has ASQ certifications in Reliability Engineering, Quality Engineering, Auditing, and Process Analysis. She recently upgraded her Exemplar Global certification from Quality System Associate Auditor to Medical Device Associate Auditor.