Ally (Lawrence) Buechler Email & Phone Number

Pleasanton, CA

Warsaw, Indiana

• Maintain EU MDD (93/42/EEC) technical files for orthopedic class I, IIa, and IIb device CE marking
• Write and review clinical evaluation reports for EU MDD (93/42/EEC) technical files
• Conduct regulatory assessments for device changes and write letters to file under the 510(k)
• Submit Annual Reports in eCTD format, Periodic Adverse Drug Experience Reports (PADER) and National Drug Code (NDC) updates to FDA for New Drug Application (NDA) maintenance
• Participate in external audits with FDA and EU Notified Bodies including front and back room support
• Compose regulatory assessments on the 361 HCT/P Status of distributed human tissue products

Warsaw, IN

• Manage clinical studies for human tissue products, IDE and post-market devices including writing protocol and case form refinement, and overseeing IRB approvals, and monitoring
• Clinical and Regulatory liaison for developing products and post market products
• Write, review and revise clinical evaluation reports, technical files and other regulatory documents for biologics and tissue products
• Compile, prepare, and submit regulatory submissions to regulatory authorities.
• Communicate and ensure regulatory submission requirements are met for timely submission and approval
• Conduct day to day activities of clinical affairs/regulatory affairs projects including study plans, timelines, risk documents, and regulatory reports.

Graduating in May 2015. Working on thesis project testing cartilage friction with osteoarthritic treatments. Using rheometry for macroscale measurements and AFM for microscale measurements.

Conducted research on the binding ability of a drug with growth factorsAssisted with drug releasing polymer film preparations and characterizing experimentsPerformed ELISA assays and experimented with cell culturesUtilized statistical analysis to confirm result validityConduct research on the release of anti-inflammatory drug from size-changing.

Utilized Western blotting and qRT-PCR techniques to characterize the effect of an immunosuppressant drug on rat insulin cells. Using immunofluorescence to visualize proteins in mice pancreatic cells. Imaged real time calcium levels in insulin cells after drug treatments

Master Of Science (Ms), Biomedical Engineering

Bachelor Of Science, Biomedical Engineering

Activities and Societies: Purduettes, Society of Women Engineers