Research Scientist II

The Texas Biomedical Device Center (TxBDC) supports active projects in vagus nerve stimulation, recovery from neurological injuries, and implantable neural devices. The Research Scientist II will help lead TxBDC clinical trials by supporting scientific progress within the framework of FDA regulations. They may also be asked to develop and provide regulatory-centric education and training to TxBDC staff, investigators and students. This position reports to the Chief Medical Officer within TxBDC.

The Research Scientist will provide direction and supervision to units engaged in research, investigation or other technical operations as well as perform research for the university.

A minimum of a PhD in a field directly related to research and a minimum of two years of experience/expertise as noted below.

The successful candidate will have a strong background in neuroscience, biomedical engineering, or a related field, with expertise in regulatory affairs, clinical research, and neurorehabilitation.

• Strong working knowledge of Good Clinical Practice ( GCP ), IRB and DSMC management, and clinical trial compliance.
• Experience independently authoring, submitting, and maintaining FDA regulatory filings for clinical studies.
• Demonstrated experience translating regulatory strategy into compliant implementation for study and site changes.
• Excellent written and verbal communication, organizational, and time management skills. Project Management experience in a clinical research environment.
• Direct experience with regulatory management for investigational neuromodulation or active implantable devices.

To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 117.001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position.

Perform all duties related to specified research which may include:

• Supervise and instruct key research personnel in work; coordinate and review the work of assigned research staff; submit project results to director and prepare and assist in the preparation of scientific papers.
• Manage FDA , IRB , and DSMC regulatory activities for multiple investigational neuromodulation device studies, including Early Feasibility and Pivotal IDE trials.
• Develop and implement regulatory strategy for multi-site investigational device studies, ensuring compliance with US regulations, standards, and guidance.
• Assess the regulatory impact of study and site changes, and guide teams through compliant implementation.
• Prepare and submit IDE trial submissions, annual reports, protocol amendments, continuing reviews, and safety notifications.
• Conduct periodic, routine audits of TxBDC clinical studies to assess compliance with GCP , study protocols, and applicable federal and state policies.
• Manage study deviations and corrective action plans (CAPAs), and coordinate study team responses to external monitoring findings.
• Develop and provide regulatory-centric education and training to TxBDC staff, investigators, and students.
• Collaborate with study teams, oversight bodies, and external partners to ensure compliant and efficient study execution.
• Stay current on national regulatory trends and best practices, and apply this knowledge to improve TxBDC’s regulatory processes and procedures.

Laboratory environment with walking/standing/sitting throughout the day. Office environment, requiring sitting at a computer for extensive time.

Internal candidates may be given preference

After the probationary period, this role may be eligible for a hybrid (partly remote/partly in office) work schedule, subject to business need and manager approval. May be required to use personal computer and other standard office equipment. Must be located within the DFW Area and have the ability to be on campus with 24…