Andrew Lasiter MS, RAC, CTBS

Accountable for leading the development and implementation of the global regulatory strategies for HCT/Ps.

• Biocompatibility SME • Articulates Regulatory Strategies • Supports Basic Market Entrance • Design Assurance –Design Quality, Safety Risk Management • EU MDR • Complaint Handling • Supports Advanced Market Entrance

▪ Manage US FDA regulatory operations (IDE, Q-Sub, FDA DRLM database) ▪ Regulatory lead on product development team ▪ EX-US regulatory strategy assessment ▪ Assessed the need and initiated change control documents ▪ Maintain CE marking for class III product portfolio ▪ Submit eMDR to competent authorities for reportable events. ▪ Work with R&D to identify and update the appropriate standards in support of new product development. ▪ Identify and implement process improvements and updates to regulatory department SOPs.

Contribute to regulatory submissions for US (e.g. 510k, PMA) and Health Canada (e.g. Class III) approvals for QIAGEN IVD products including reagents and instrumentation/software. TrackWise QMS administrator for international regulatory submission processes. Business Intelligence report creation for international regulatory license rationalization.

Support the development and implementation of the overall objective and regulatory strategies that impact the introduction of new products and the market status of existing products. Prepare dossiers for international markets to obtain and maintain global regulatory approvals of products. Analyze downstream outcomes of US and international regulatory policy changes on medical device registrations. Identification and resolution of international issues for quick product approval and marketability in emerging markets Manage the creation, implantation and streamlining of regulatory department databases Promote cross-functional department projects to increase inter-departmental communication in order to significantly decrease product approval times and speedup time to marketability Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents

Hematology Department: Optimizing ex vivo expansion and self-renewal of hematopoietic stem cells through canonical Wnt pathway antagonists for lentiviral vector based transduction approaches of globin gene prodcuts for treating beta-thalassemia