Melissa Sanchez

Staff Regulatory Affairs Specialist @Werfen

Austin, TX, US

Responsible for the implementation of Regulatory Affairs functions (regulatory strategies, product registrations, etc.) to adhere to U.S. and international medical device/IVD regulations for the company’s newest product line (instrument, software, assays) and to support company objectives and Quality System activities (ISO 13485:2016, MDSAP). Responsible for the review of labeling and advertising/promotional materials, mentoring/training of junior team members, and advising on the implementation of compliance mechanisms for new and emerging regulations, standards, and regulatory guidance documents.• Regulatory Affairs representative on cross-functional product development teams (new product introduction and design changes) to ensure the company’s regulatory compliance and to increase product offerings.• Author and manage Technical Documentation for new and legacy device submissions under EU IVDR (Class A and B) and act as representative with the applicable regulatory authorities to ensure compliance to IVDR and appropriate EU directives (e.g, Machinery, RED, REACH, etc.). • Authored pre-submission to gain insight from the FDA to met company objectives.• Coordinate cross-functional team responses to regulatory authority questions on submissions (510(k), IVDR, international registrations).• Improved internal procedures related to regulatory strategy and labeling to support new product and design change strategy planning and labeling activities in the North American and European markets.

Texas A&M University

Bachelor's Degree