FDA IND-IDE Specialist

Position Summary
The temporary FDA IND / IDE Specialist is responsible for the organization coordination review and submission of regulatory documents supporting Investigational New Drug ( IND ) applications Investigational Device Exemption ( IDE ) applications amendments supplements annual reports and related FDA communications. This role ensures compliance with applicable FDA regulations Good Clinical Practice ( GCP ) and other regulatory requirements governing clinical research involving drugs biologics and medical devices. The specialist collaborates with the Clinical Trials Quality Assurance team and may interact with clinical research teams to ensure regulatory documents within regulatory submissions meet all submission requirements. This position is important to the departments goal of increasing the audits we complete as well as continuing to provide excellent customer service. Because audits are generally scheduled and FDA submissions are not it is challenging to manage the often-competing deadlines. Hiring a Temporary position to assist with FDA submissions will allow the auditors to better focus on audit completion. This increases our customer satisfaction as it allows us to complete audits in a timely manner. Additionally hiring a Temporary position allows the department to make the best use of its resources because this will allow the higher paid auditors to focus on audit specific work. IND Responsibilities: Organize compile review and submit IND applications amendments safety reports annual reports and FDA correspondence. Coordinate cross-functional contributions for Chemistry Manufacturing and Controls ( CMC ) nonclinical clinical and investigator information sections. Ensure IND submissions comply with FDA regulations guidance documents and eCTD requirements. Track submission timelines and FDA review milestones. Support responses to FDA information requests clinical holds and deficiency letters. Maintain regulatory submission archives and documentation. IDE Responsibilities: Organize and submit IDE applications supplements amendments progress reports and device-related FDA communications. Perform a cursory review of device development documentation risk analyses and clinical investigation plans. Coordinate with the clinical research teams to support IDE submissions. Ensure compliance with FDA device regulations and investigational device requirements. Monitor IDE approvals modifications and post-approval obligations. Regulatory Compliance: Interpret FDA regulations and guidance documents relevant to clinical investigations. Ensure compliance with: 21 CFR Part 312 (Investigational New Drug Applications) 21 CFR Part 812 (Investigational Device Exemptions) 21 CFR Parts 50 54 and 56 ICH - GCP Guidelines Applicable FDA electronic submission requirements Support inspection readiness activities and regulatory audits. Maintain accurate records of regulatory submissions and approvals. Provide submission status updates to project leadership.