Melissa Abreu Email & Phone Number

Orlando, Fl, Us

Orlando, Fl, Us

Roseland, New Jersey, Us

Eagan, Minnesota, Us

New Brunswick, Nj, Us

In my previous role at Johnson & Johnson, I collaborated with various countries to ensure medical devices were properly distributed by providing country specific documentation, letters, and certifications. I composed and circulated letters to appropriate franchise signees. Documentation that requires notarization, apostilled, and hard copies were provided to signees. Once these documents were approved, the country received to release product in their regions preventing delays and back-orders.

Orlando, Fl, Us

In my role at Xymogen, I supported government audits and correspondence as well as executed standard operating systems to increase efficiencies. I communicated with suppliers to address technical research inquiries. Also, I researched and analyzed data related to product claims.I reviewed private label/Xymogen products and processed new vendor qualification applications for distribution. I ensured compliance with FTC, FDA, USDA, and other regulatory standards to implement best practices.Selected Contributions:• Acted as Primary Lead to support company on launch of new part of business.• Reviewed 900 products while serving as Regulatory lead for a brand new area of Xymogen called Wholescripts.

Ewing, New Jersey, Us

In my role as Regulatory Affairs Associate, I created and submitted reports to senior management on overall progress and status of project. I have gained complete understanding of current government regulations that affect product lines. Also, I deployed Unique Device Identifier (UDI) system for Class I and Class II medical devices compliance.In addition to this, I have cultivated productive relationships with Church & Dwight and government agencies on assigned projects through responsive and open communication. Also, I managed data collection for FDA user fees and regulatory documents in collaboration with senior regulatory personnel. I have prepared and updated electronic safety and medical device reports improving timeliness.Selected Contributions:• Analyzed consumer adverse event complaints by cross-referencing CPSC and FDA regulations by serving as an active member of Reportability Review Committee.• Updated manufacturing facility registrations and state licenses in compliance with Department of Agriculture, Board of Health, and Board of Pharmacy standards.Additional ExperienceConsumer Relations Representative, Church & Dwight Co., Inc. Princeton, New JerseyClient Relations, Argix Logistics, Inc. Jamesburg, New JerseyHigh Volume Installation Coordinator, ADT Security Services, Inc. Edison, New Jersey

Business Administration And Management, General

Certificate, Design And Visual Communications, General