Luis Santiago

About Luis Santiago

Regulatory Affairs and Quality professional within Medical Device spanning from complaint…

Experience

1. Regulatory Affairs Specialist

   Philips

   Jan 2024 — Present · Orlando, FL, US

   Supports and provides regulatory expertise to assigned medical devices and consumer product development projects from initial kickoff to post marketing phase- Creation and execution of complex Regulatory Strategies and Plans for assigned medical devices and consumer products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers- Develops the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released- Prepares and submits US FDA pre-sub, 510(k), and other product submissions according to FDA guidelines- Creates EU Technical File and Declaration of Conformity documents (MDD, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines- Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US (FDA), EU (MDD), and CA (Health Canada)- Support the international regulatory specialist team with inputs, as needed, into the registration packages they prepare.

Education

• Florida International University

  Master's degree, Health Services Administration

• Florida Atlantic University

  Bachelor of Science (BS), Biology, General

• Broward College

  Associate of Science (AS), Biology, General