The Texas Biomedical Device Center (TxBDC) supports active projects in vagus nerve stimulation, recovery from neurological injuries, tinnitus therapies, and implantable neural devices. The Senior Regulatory Engineer will help with and/or lead the Quality Assurance and Regulatory needs of the TxBDC. 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 Technology Officer within TxBDC. The Sr. Regulatory Engineer will work cross functionally within the TxBDC to help navigate the regulated environment in the fulfillment of TxBDC clinical research projects and initiatives. Responsibilities include assisting with, developing, implementing, or managing a broad range of regulated activities such as:
regulatory and clinical research and strategy development;
regulatory compliance with required US and OUS regulations, standards and guidances
Product Verification & Validation activities
Creation of design history file and associated project management
Co-ordination of outsourced preclinical GLP/GMP safety & efficacy testing;
IRB/IDE presub planning & preparation;
IRB/IDE application project management and creation;
register clinical studies on clinical trials.gov;
Assist cross-functional resources with preparation, handling, distribution and tracking of clinical trial product;
Co-ordinate and manage any external regulatory or quality system audits
Experience with electrical safety and electromagnetic compatibility testing and certification. (such as IEC 60601-1, 60601-1-2 and FCC radio testing and certification).
Other activities will include TxBDC quality system activities such as:
document controls and records management and retention;
Creation and implementation of Standard Operating Procedures, tools and templates for the various regulatory, quality, and clinical research activities relating to the development and implementation of novel therapies and devices;
Conduct periodic, routine audits of the TxBDC to assess compliance with applicable federal, state and UTD policies
Provide quality oversight for key TxBDC suppliers including supplier selection, creation of supplier contracts, co-ordination of supplier validation activities and conduct of supplier audits.
Perform other duties as assigned.
Bachelor's degree and at least 5 years of related medical device regulatory experience. Excellent knowledge of regulatory affairs, regulatory guidance and medical device regulations applicable to product development, manufacturing, regulatory pathways and submissions. Strong working knowledge and demonstrated experience with quality management principles, quality systems, audit techniques, concepts and standards. Excellent written and verbal communication, organizational and time management skills. Experience independently writing and preparing medical device regulatory submissions and receiving approval. Experience working with FDA to determine regulatory pathways and regulatory requirements for medical devices. Demonstrated ability to manage competing priorities and multiple projects under varying time constraints.
Preferred: Advanced degree preferred. ISO13485 Lead Auditor, Manager of Quality/Organizational Excellence, Biomedical/Quality Auditor Certifications desired. Experience with Complaint handling and/or adverse event reporting to regulatory agencies. Ability to lead regulatory initiatives. Project Management experience preferred. Experience in developing and implementing training/education materials for university environment preferred.
Preferred Education and Experience:
Advanced degree preferred. ISO13485 Lead Auditor, Manager of Quality/Organizational Excellence, Biomedical/Quality Auditor Certifications desired. Experience with Complaint handling and/or adverse event reporting to regulatory agencies. Ability to lead regulatory initiatives. Project Management experience preferred. Experience in developing and implementing training/education materials for university environment preferred.
1) The University of Texas at Dallas is an equal opportunity/affirmative action employer (M/F/D/V).
2) All employees serve as a representative of the University and are expected to display respect, civility, professional courtesy, consideration of others and discretion in all interactions with members of the UT Dallas community and the general public.
Internal Number: 9598
About The University of Texas at Dallas
The University of Texas at Dallas is an innovative institution in the heart of North Texas on the path to achieving Tier One national research university status.UT Dallas has grown since its founding in 1969 to include 132 degree programs, with cutting-edge curricula serving a variety of undergraduate and graduate student interests.The University continues its original commitment to providing some of the state's most-lauded science and engineering programs and has also gained prominence for a breadth of educational paths, from criminology to biomedical engineering to arts and technology.The wealth of learning resources available to UT Dallas students is the result of a concentrated effort to attract the top minds on both ends of the classroom relationship. Joining the faculty's Nobel laureate and four National Academies members since 2005 are more than 200 tenure and tenure-track professors hailing from the world's best colleges, including Harvard, MIT, Cambridge and Columbia University. In addition, UT Dallas is home to more than 50 centers, labs and institutes that facilitate research and opportunities for hands-on learning. Students, meanwhile, arrive at UT Dallas well-prepared ...to succeed in higher education: In 2011, nearly 39 percent of freshmen ranked in the top 10 percent of their high school class, and 75 percent ranked in the top 25 percent.With an eye on building a future as bright as its beginnings, UT Dallas will continue its push to attain Tier One research university status and produce graduates who are well-equipped to succeed professionally.