Functional Skills

Industry Expertise

Software Skills

Microsoft Word
Microsoft Excel
Microsoft Office
Microsoft PowerPoint
Microsoft Visio
Microsoft Project
Dropbox

Certifications

PMPProject Management Professional

Sector Experience

Healthcare
Telecom
Technology
Life Sciences & Pharma
Transportation & Logistics
1
jobs

Jobs Completed

1
hours

Total Hours Logged

17
years

Years of Experience

2/20

Member Since

Experience

 
 
Management Consulting
Calyx Consulting, LLC - President/Owner
02/2005 - Present
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

 
Marketing
Boston Scientific - Principal Medical Writer
12/2019 - 05/2021
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.

 
Management Consulting
Oriel STAT A MATRIX - Affiliate Senior Consultant
03/2018 - 02/2021
• 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

 
Other
Self-Employed - 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 under
01/2014 - 01/2021
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

 
Management Consulting
Baxter International - Global Clinical Research Consultant
03/2019 - 08/2019
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.

 
Marketing
Maetrics - Senior Associate
10/2018 - 12/2018
• 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.

 
Management Consulting
Philips - Senior Clinical Affairs Consultant
05/2018 - 10/2018
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.

 
Marketing
Imangel Consulting, LL - QA/RA Consultant for Medical Devices
03/2013 - 10/2015
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
General Electric - Strategy Leader
07/2006 - 07/2010
Start-up division within a large corporation in telematics industry. GPS Tracking Devices for the transportation industry