Requirements: Master’s degree in Material Science, Biochemistry, Quality Assurance or related biology/science field and three (3) years experience as a senior regulatory affairs analyst, senior quality control/assurance analyst or related occupation in regulatory affairs; OR Bachelor’s degree and five (5) years experience as a senior regulatory affairs analyst, senior quality control/assurance analyst or related occupation in regulatory affairs. ( 15% ) Support development teams working towards modifying existing processes or creating new processes; ensure compliance with existing design controls, risk management, and domestic and international regulations.( 5% ) Ensure timely approvals, communicate, and support negotiations with the FDA and other regulatory bodies as needed to identify pre-submission requirements and strategy and to resolve post-submission queries and issues.(