Lilly Mercado
@lillymercado
I lead global medical-device regulatory submissions, quality systems, and compliance programs.
United StatesWhat I'm looking for
I'm currently leading regulatory affairs and quality assurance at HARPS USA, managing license renewals, labeling reviews, recalls, complaint management, facility registration, training, and FDA and Health Canada correspondence.
I've delivered EU MDR, MDD, SaMD, IVD, and international regulatory work for Cook Medical, Medtronic Diabetes, Cardinal Health, Arthrex, Meridian Bioscience, AngioDynamics, Hollister, and Hospira. My work includes STED submissions, technical files, clinical evaluation reports, product change assessments, registrations, renewals, audits, quality agreements, and regulatory process improvement across LATAM, APAC, MEA, Canada, the U.S., and Europe.
I bring hands-on quality systems experience in complaint management, post-market investigations, labeling, distribution quality, supplier quality, training, and Lean Six Sigma process improvement.
Experience
Work history, roles, and key accomplishments
Manager of Regulatory Affairs and Quality Assurance
Harps USA, Inc.
Apr 2024 - Present (2 years 4 months)
Member of leadership team overseeing license renewals, regulatory compliance, complaint management, and quality issues. Serves as FDA and Health Canada correspondent and manages employee training and quality agreements.
Completed regulatory submissions for LATAM and MEA regions during a short-term part-time contract.
Worked on software as a Medical Device (SaMD) STED EU MDR submissions for Class IIa and IIb devices. Conducted regulatory impact assessments for product change notifications and supported responses to notified body deficiencies.
Updated technical files and design dossiers under MDD and created the template and pilot submission under EU MDR. Authored a Clinical Evaluation Report and wrote several SOPs.
Senior Principal Specialist Consultant
Independent Consultant
Mar 2018 - Dec 2018 (9 months)
Provided regulatory consulting for clients transitioning from EU MDD to EU MDR, including gap analysis, template reviews, and pilot submissions.
Managed domestic and international submissions for IVD devices, including SaMD, and created templates for submissions. Authored a 510(k) and renewals for Canada and other countries.
Investigated and handled complaints and adverse events in a post-market regulatory capacity. Interfaced with medical personnel to document details of product complaints and assessed reportability.
Prepared international submissions for registrations, renewals, and amendments for APAC, LATAM, and EMEA. Led regulatory projects and served as SME on new product development teams.
Global Regulatory Affairs Consultant
Hospira
Jan 2013 - May 2014 (1 year 4 months)
Supported US and international submissions and worked on data gathering for a large regulatory database project. Provided gap and risk analysis and assisted with FDA and NSAI audits.
Education
Degrees, certifications, and relevant coursework
Dominican University
Bachelor of Arts, Biology
Bachelor of Arts in Biology with a minor in Chemistry.
Hines V.A. School of Nuclear Medicine
Certificate, Nuclear Medicine
Nuclear Medicine Certificate program.
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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