Alexander Borremans Email & Phone Number

Houston, Texas, United States

• Developed and optimized corporate processes and Standard Operating Procedures (SOPs) to enhance efficiency in cross-functional tasks requiring collaboration among multiple departments.
• Engaged in comprehensive post-market surveillance activities, including Medical Device Incident Reporting (MIR) and Medical Device Reports (MDR) submissions, effectively managing adverse event reports, PMS reports.
• Facilitated the collection of essential documents for internal and external audits, ensuring seamless compliance with regulatory standards.
• Oversaw the company's regulatory document control system, meticulously maintaining accuracy and adherence to regulatory requirements.
• Assisted in the preparation and submission of complex regulatory applications, including FDA 510(k), Pre-market Approval (PMA), Add-to-File, and Emergency Use Authorization (EUA) applications for in-vitro diagnostic.
• Spearheaded the implementation of an advanced electronic document management system, optimizing regulatory document control processes for enhanced efficiency and accuracy.

Houston, Texas, United States

Collaborated with the marketing team while working closely with customer service, sales, quality, R&D, clinical affairs, warehouse, clients, and partnerships. Spearheaded the inbound market research for proposal and development of new and current products. Responsible for gathering relevant industry news covering health events, FDA and CDC newsletters.

Bachelor'S Of Science, Health Science, 3.3 Cum. Gpa; 3.7 Major Gpa

Activities and Societies: Club Soccer, Dean's List, Honors Society, BearKat Transfer Scholarship, Renewal Bearkat Transfer Scholarship.

3.3

Activities and Societies: Deans List, and Honors Society