Technical Writer and Project Manager with extensive experience in:
• Proposal Responses including US government agencies
• B2B White Papers and Case Studies
• Quality Management Systems
• Risk Assessment, Mitigation Plans, and Risk Management
• New Product Introductions

Part of a project team tasked with reviewing, editing, and writing documentation for compliance with the EU MDR. Specific deliverables include:
• Review clinical data (text journaled articles) and develop a data extraction table with specific inclusion/exclusion criteria for the company’s urology devices.
• Create a Clinical Data Report and Clinical Evaluation Report based on review of previous documentation and the articles reviewed. Develop a strategy for compliance to the EU MDR.

• Oriel STAT A MATRIX helps organizations reduce costs and risk by achieving compliance with global regulations and improving business processes. As a Project Manager, projects are offered on an as-needed basis as a QA/RA consultant for medical devices.
• Work projects on an

Self-Directed Investor
Due to a multi-decade interest in the financial markets and some negative experiences with paid financial planners, took on the responsibility of undertaking what turned out to be a huge challenge. Learned how options investing and the benefits it can bring in this low-interest rate environment. Important aspects include:
• Statistical analysis - critical to successful investing
• Risk management for capital preservation

Member of the Global Medical Affairs team responsible for ensuring the company’s entire portfolio of medical devices is compliant with EU MDR 2017/745 for Europe and other countries where the regulatory framework requires CERs (i.e. APAC region including China).
• Develop and write Global Quality Processes (GQPs) and Templates as part of the company's overall quality strategy.
• Led a CER remediation project for a Class III device to comply with NB deficiencies to comply EU standards.

• Clinical Consultant with responsibility over multiple projects. Assist clients to comply with the EU MEDDEV 2.7/1 rev.4 by writing a CEP and a CER for a Class IIb device for an NPI. Wrote a PMS plan and a PSUR for a marketed Class IIb device.

Part of a project team tasked with reviewing, editing, and writing documentation for compliance with the EU MDR regulation 2017/745 for ultrasound devices. Specific deliverables:
• Device Gap Analysis based previous Clinical Evaluation Reports (CERs).
• Develop a Clinical Evaluation Plan (CEP) template.

Subcontractor for a medical device consulting firm. Led regulatory projects for both initial product launch and ongoing requirements to continue marketing devices in the US (FDA), EU, Canada (CDRH), and China CFDA (now known as National Medical Products Association NMPA)

Start-up division within a large corporation in telematics industry. GPS Tracking Devices for the transportation industry