Sean Spence Email & Phone Number

Indianapolis, In, Us

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana

▪ Wrote and submitted global submissions (e.g., 510(k)s, 513(g), Q-submissions, Class III Technical Documents, Significant Change Notifications, etc.) for CNS neurosurgical electromechanical tools▪ Part of lead team during ISO 13485, MDSAP, and FDA QSIT inspections▪ Facilitated development projects by providing regulatory pathway and verification testing selection (e.g., sterility, biocompatibility)▪ Helped and led Quality System initiatives including EU MDR, UDI, cleaning validation, supplier audits, recalls, change requests, and marketing piece review.▪ Facilitated the development and execution of the on-going ENRICH Clinical Trial (NCT02880878), along with small-business grant opportunities▪ Aided NICO’s global expansion through registrations, distributor setup and quality agreements

Bloomington, Indiana Area

▪ Guided development projects through the design control process as a part of a cross-functional team▪ Completed numerous 510(k), EU, Shonin, Ninsho, and Health Canada medical device submissions, including drug device combination products and EU CTD documentation for combination devices▪ Supported submission efforts in many other global markets including China, Korea, Australia, South America, and the Middle East▪ Prepared and attended several PreSubmission meetings with FDA as well as a combination device major consultation with PMDA (Japan)▪ Reviewed marketing pieces and device labeling for various global markets▪ Asked to lead cross-functional regulatory affairs team as Team Leader supporting the Critical Care, Interventional Radiology, and Surgery business units and development engineering teams▪ Wrote personnel training plans and gave performance reviews for team members

▪ Worked with method validation and writing standard operating procedures▪ Lead teams on OOS and CAPA guidance projects▪ Performed monthly new hire training seminar▪ Performed routine analytical chemistry and biological testing▪ Asked to lead laboratory functional unit as Supervisor in 2009▪ Coordinated weekly laboratory testing and personnel schedule▪ Wrote performance reviews for laboratory personnel

▪ Analyzed products in a Bioanalytical Quality Assurance Chemistry Lab while maintaining product availability and a zero percent product recall▪ Fully certified within half the allotted time frame▪ Performed daily GMP duties carried out in accordance with good manufacturing and lab practices▪ Worked with validation and familiarized in writing standard operating procedures▪ Served as Lab Safety Officer. Duties included projects and presentations as well as FDA inspection/audit readiness▪ Served as Lab Calibration team member, responsible for handling equipment calibration, preventive maintenance and repair