Eric Vazquez Email & Phone Number

Gainesville, Florida, United States

Oversee all labeling documentation for EU MDR submissions, 510(k) submissions, and responses to Regulatory Affairs bodies at Exactech Inc.Ensure compliance with global medical device regulations and manage labeling for new product development and maintenance projects.Collaborate with Regulatory, Engineering, Development, and Packaging teams to create and approve compliant labeling.Serve as the company-wide Subject Matter Expert (SME) for labeling, providing guidance and support across various workstreams.Coordinate with vendors for translation, printing, and other services to ensure accurate and timely deliverables.Leverage expertise in PRISYM 360 labeling systems to streamline and enhance labeling processes.

Florida, United States

Responsible for the management of regulatory activities pertaining to products under development (New Product Development (NPD)) as well as those currently registered and marketed (Product Life-cycle Management (PLCM)) in the US. Responsible for providing technical and scientific advice, support and service to Quality, Research and Development, and Sales and Marketing functions in the development of effective regulatory strategies. Responsible for compilation and submission of dossiers for registration of Apotex products in identified markets.

Miami/Fort Lauderdale Area

Supports the regulatory affairs team by compiling new drug information and changes for submission to the Food and Drug Administration (FDA) for approval.Oversee post drug adverse effect reporting for all products and review submissions inadvance to meet all FDA requirements.Monitored Abbreviated New Drug Applications (ANDA) to ensure accuracy, thoroughness and completeness.Entrusted to lead three year-long ANDA submissions for Aveva Drug Delivery Systems Inc.; gathered required information, drafted summaries and ensured timely and accurate final submission.Trained an offshore team of 10 in India on best practices related to the preparation and submission of post drug adverse effects reports for products.

Miami/Fort Lauderdale Area

Provided shift leadership in absence of the store’s Manager. Oversaw inventory, ensured visual appeal of the store and met each customer’s needs. Recognized with the store’ first-ever “Partner of the Quarter Award”.

Miami/Fort Lauderdale Area

In this consultative sales role, sold computer systems, related products and services to a wide range of customers.