Project Manager

• 2018 - Present

Architectural Drafter

• Oct 2015 - Present

Freelance Designer

• 2008 - 2014

- Create design concepts to meet client and site requirements. - Prepare architectural drawings, plans, renderings and documents for statutory approvals - Provide interior and architectural services for residential and commercial buildings (remodels, additions and tenant improvements). - Design and development of marketing collateral materials and community outreach projects. - Provide Design Research Services including: qualitative and quantitative data collection, analysis and design proposals. Show less

Regulatory Affairs Coordinator

• Jul 2009 - Aug 2013

- Completed new device opportunity assessments and developed new standard operating procedures for latest products. - Assisted with the review, approval, and documentation of marketing collateral material and manufacturing procedures and protocols. - Supported Regulatory Affairs department in quality systems compliance in accordance to the Food and Drug Administration, Quality Systems Regulation, and International Organization for Standardization 13485:2003. - Exported medical devices internationally. Researched and created first guide with step-by-step procedures that needed to be followed according to each countries’ standards during each transaction. - Applied for and renewed national and international distribution licenses for all medical devices according to protocols and sales regulations. - Maintained hard copy and electronic files ensuring documentation for audits were organized, accurate, and in compliance with all regulations. - Performed corrective and preventive action activities including: original equipment manufacturer change monitoring, post-market risk assessments, patent searches, documentation of recalls, and ratification letters. - Collaborated on research and review of Premarket Notifications (510(k)s). Show less

Project Manager

• 2006 - 2008

- Coordinated entire development process for land development projects (Zoning, Construction, Finance, LLC Formation, and Marketing). - Assisted with the design and development of architectural construction documents and renderings. - Assisted with the rezoning and city building and construction permits and community outreach activities. - Coordinated LEED certification process. - Assembled due diligence packets for financial institutions. Detailed coordination and organization of documents from multiple public and private entities. - Created graphic design and marketing collateral material for all land development projects and company literature including brochures, signs, marketing packages, and website design. Show less