Amy O'Donnell Email & Phone Number

Bedford, Ma, Us

Malvern, Pa, Us

Raritan, New Jersey, Us

Billerica, Ma, Us

Responsible for Premarket Regulatory Affairs associated with 510(k) submissions, Design Examinations, maintenance of Technical Files, and establishment registration. Responsible for reviewing documentation changes and nonconforming material reports for compliance with regulations and submission content. Ensured design, manufacturing, and software was compliant with regulations and submission content. Developed the regulatory strategies for multiple devices and geographies. • Facilitated several successful 510(k) premarket notifications for new and changes to proprietary software modules, product design changes and indications– 100% of all submissions have resulted in a decision of substantially equivalent• Worked as an integral member of several cross functional teams (including R&D, manufacturing, software, and quality) to ensure timely delivery of critical milestones towards product realization – this includes major design changes to current instrumentation and commercialization of new implant systems.• Provided guidance to product development groups to ensure testing met regulatory and quality requirements • Created Clinical Evaluation Reports for new materials, design changes, and certificate renewal• Conducted quarterly internal audits on various areas of the Quality Management System• Participated in third party audits (i.e. Notified Body and FDA)• Reviewed advertising and promotional material to ensure claims were supported and consistent with cleared claims• Updated labeling including package insert and surgical technique guides to include various product updates• Initiated internal training sessions on the quality management system, advertising and promotion for medical devices, and conducting off-the-shelf software validations.

Raynham, Ma, Us

Responsible for Post Market Regulatory Affairs associated with complaint handling and MDR submissions, including documentation management and metrics. Responsible for oversight of technical evaluations and investigational tasks required for complaint process/closure. Also generated compliance and customer complaint trending and tracking reports to alert management to potential problem areas.• Team member of project management team to develop and implement the new complaint handling software – CATSWeb• Created reporting requirements and standardization of complaint entry which increased consistency, quality, and ease of generating department metrics• Developed Visual Basic macros which reduced the metric generation time by 40%• Streamlined the complaint product investigation process which eliminated several bottlenecks and reduce the investigation backlog

Raynham, Ma, Us

Responsible for coordination of Field Action execution including investigation of non-conformance, development of recall action plan, notification of recall to accounts, affected employees and regulatory bodies, metrics, effectiveness checks, and termination. Ensured that the strategy is compliant with regulations and FDA guidance. Also interfaced with accounts and sales consultants regarding product criticism.• Supervised temporary employees including training, prioritization of recall tasks, and performance reviews• Field action expert on team to update recall database to use a mailing list algorithm to reduce the number of duplicate field action notifications• Created and maintained field action internal website to allow management to see the current status of each recall and which of their department tasks are still open • Completed software validations to implement process improvement changes to the field action database

Raynham, Ma, Us

Responsible for reviewing and entering manufacturing and design change controls. Interacted with manufacturing and quality to ensure that appropriate documentation was approved and maintained in the Device Master File and Device History File.• Assisted Quality Engineering a project to develop inspection instructions for all manufactured and purchased assemblies and sub-assemblies – ~40% of the needed documentation was generated in 2 months. • Streamlined departmental procedures which reduced documentation processing time by 50%• Supported and interacted with auditors• Assisted several lean six sigma projects as the Document Control expert

Certificate, Biopharmaceutical Domestic Regulatory Affairs

Mba, Accounting And Finance

Bs, Bioinformatics