Nicholas Ferrer Email & Phone Number

Johnston, Ri, Us

Somerville, Massachusetts, Us

Transforming the clinical industry with cutting-edge artificial intelligence (AI) technology. This position supports the Data Science Office and Digital Clinical Research Office (CRO) ensuring compliance with international, regional, local, and cultural standards/regulations.

Shelton, Ct, Us

•FDA Inspection front/back-room support •Internal Audits - site process manager -proficient in ‘ISO 19011 - Guidelines for auditing management systems•Management Review - site process manager•Create, Review and Release engineering change orders for medical devices, new products, and supporting documentation• Create and maintain Quality System Management procedures establishing compliance standards• Primary resource for medical device Software Release - change order reviewer/approver; responsible for transfer of software into production environment• DHR - quality review and approval of finished medical devices

Ma, 01824, Us

EN 60601-1:2012 Compliance EN 60601-1-2:2015 Compliance EN 60601-2-4:2011 Compliance EN ISO 14971:2012 Compliance EN ISO 15223-1:2012 ComplianceANSI/AAMI EC12:2000 ComplianceANSI/AAMI EC53:2013 ComplianceAAMI DF80:2003 ComplianceDesign History File Auditing: • System Requirements Documents • Design Input / Output Guides • Usability Specifications • Risk and Hazard Analysis • Design Verifications and Validations • DFMEAs • PFMEAs • Material Specifications • Standard Inspection Procedures • Standard Operating Procedures

Providence, Ri, Us

Design of ExperimentsClass 7 & 8 Clean Rooms: • Installation Qualification Protocol generation • Operational Qualification Protocol generation • Performance Qualification Protocol generation

East Providence, Ri, Us

• ICH/GCP Certification.• Maintained study trackers/ dashboards to assist management with ongoing oversight of clinical trial program.• Responsible for the distribution and management of clinical trial supplies.• Reviewed and tracked site visit reports. • Assist in administrative tasks/ Prepare submissions to Ethics Committees and Competent Authorities under supervision.• Review site budgets and assist in overall study payments.• Maintained Trial Master Files.• Participated in vendor meetings and internal study team meetings.• Assisted with overall study management for 3 orthopedic device clinical trials in US and Europe that will be used for regulatory submissions.

East Providence, Ri, Us

• Built prototypes, models, test fixtures and mechanical systems.• Provided product/material testing and evaluation of statistical analysis.• Independently designed and executed simulated-use experiments, which included data analysis and communication regarding improvements.• Wrote and revised technical documents including SOP’s, design verifications, test protocols and reports.• Optimized data management system by enhancing the maintenance of accurate and up to date records, including appropriate lab notebook recordings.• Experience operating in clean rooms and with FDA Systems Regulations.• Produced manufacturing documentation for medical devices that incorporates the input from cross-functional and highly dynamic development teams.• Managed several projects from conceptualization to production of various medical devicecomponents/accessories including the generation and maintenance of the Technical Files.• Development and creation of Instructions for Use, Surgical Technique Guides and Labeling forcommercial/ clinical product.

Master Of Science - Ms, Regulatory Affairs For Drugs, Biologics And Medical Devices

B.S., Electrical Engineering

B.S., Biomedical Engineering, Nanotechnology