Key Contributor & Effective Leader supporting quality assurance and clinical research functions in fast-paced and high-stress environments within a variety of industries. Experienced in overseeing complex internal audits, supervising staff members, implementing long-term strategic models, and fostering positive relationships with internal clients. Equipped with a significant ability to leverage skills in project management and to introduce new tools for cost/time savings.

Operations Management Clinical Research Standards Team Leadership Change Request Management

Regulatory Compliance Product Line Development RAD/Agile Methodologies Project Management

Process Improvement FDA Regulations Project Management Strategy Design/Implementation

  Direct day to day research operations within a fast-paced environment with a focus on increasing productivity and efficiency levels

  Play a lead role in preparing and submitting both IND and IDE applications to the FDA, monitor application status, and submit amendments to annual reports

  Provide administrative support to Principal Investigators in regards to submissions to the FDA and/or other regulatory agencies in addition to identifying adverse events and generating repots outlining submission timelines

  Act as the Authorized Sponsor Representative for the FDA, generate reports highlighting adverse events, and maintain positive rapport with government agencies

  Coordinated regulatory functions within a successful medical device company with a focus on guiding project teams and supporting implant modifications

  Recognizes as the Regulatory Representative for several projects based in Germany, maintained a significant knowledge of both domestic and international regulatory changes, and assessed regulatory impact on potential product changes

  Planned and submitted international regulatory submissions, reviewed change orders, and designed innovative standard operating procedures within the Regulatory Affairs department

  Successfully ensured compliance with ISO 13485, 21 CFR 807, 21 CFR 814, and 21 CFR 820 in addition to handling change management tasks requiring knowledge of RAD/Agile methods

  Member of several product teams which are tasked with developing innovative regulatory strategies, product timelines, and deliverables

St. Jude Children s Research Hospital 2005-2014

  Handled various regulatory and QA functions within a research hospital environment which included completing compliance audits and ensuring SOPs were followed

  Created internal processes which complied with GMP, GTP, and FACT regulations along with developing comprehensive audit reports and revising best practices as needed

  Performed detailed investigations requiring the development of corrective/preventative actions, reviewed final product labeling, and maintained change requests