Melissa Perez
Lake Mary,FL
Summary
Investigative regulatory professional focused on compliance and project execution across EMEA, APAC, and LATAM. Managed audits and submissions, ensuring compliant devices while leading cross-functional teams to effectively resolve regulatory challenges. Aligned technical documentation with EU MDR standards to enhance operational efficiency.
Overview
6
6
years of professional experience
Work History
Regulatory Affairs Specialist II
Johnson & Johnson
Palm Beach Gardens, Florida
03.2025 - Current
- Managed regulatory actions for EN 60601-1 and EN 60601-1-2 requirements, delivering compliant devices and labeling for LATAM, APAC, and EMEA regions.
- Oversaw publication and upload of five electronic IFUs and regulatory updates, ensuring compliance with EN 60601-1 and EN 60601-1-2 standards.
- Communicated Legal Manufacturer 2D UDI updates to maintain EU MDR compliance, coordinating dissemination to APAC, LATAM, and EMEA regulatory teams to enable assessment and planning of applicable Health Authority submission requirements.
- Led coordination of deficiency responses between the Legal Manufacturer and Notified Body during a Technical Documentation Surveillance Audit, facilitating timely resolution of regulatory findings and achieving successful audit closure.
Regulatory Affairs Specialist I
Johnson & Johnson
Palm Beach Gardens, Florida
11.2022 - 03.2025
- Drove regulatory excellence as RA lead for lifecycle management project of four medical device batteries totaling $23.9M.
- Managed legal manufacturer change project, overseeing labeling updates, IFU revisions, technical file releases, and EUDAMED data entry to ensure compliance.
- Executed design dossier for MDR (2017/745) Class III device, including GSPRC documentation and applied standards.
- Coordinated regulatory affairs teams in APAC and LATAM to improve submission timing and reduce backorders.
- Led technical file surveillance audit, collaborating with SMEs to ensure compliance and timely responses.
- Supported MDSAP TUV surveillance audit by drafting auditor requests and consulting with SMEs to meet requirements.
R&D Associate
Garden of Life
Palm Beach Gardens, Florida
11.2020 - 10.2022
- Established database of 100+ raw materials and 20+ formulas in Genesis, a supplements labeling software, and maintained tracker to enhance efficiency and transparency in formula development
- Evaluated 50+ product formulas to assess impact of raw materials and utilized findings to develop Bill of Materials (BOMs)
- Streamlined WERCSmart uploads, increasing efficiency by 90% and eliminating backlog, ensuring timely uploads of finished goods for vendor and retailer access to SKUs
Supplier Quality Engineering Intern
AbbVie
Madison, New Jersey
06.2020 - 08.2020
- Created database of 150+ active R&D suppliers, consolidating inputs from chemistry manufacturing and controls (CMC) and quality management system (QMS) to improve supplier tracking.
- Developed three standard operating procedures for PDQA, standardizing R&D audit processes from execution to closure to ensure consistency and compliance.
- Streamlined data collection from CMC and QMS, improving accuracy of supplier database and facilitating better supplier evaluations.
Education
Bachelor of Science - Interdisciplinary Business, Innovation & Tech
The College of New Jersey
Trenton, NJ05-2020
Skills
- EU MDR 2017/745
- Regulatory compliance
- Regulatory strategy
- Regulatory auditing
- Technical file management
- 510(k) documentation
- EUDAMED
- Regulatory software applications
- Project management
- Risk management
- Technical writing
- Problem solving
Timeline
Regulatory Affairs Specialist II
Johnson & Johnson
03.2025 - Current
Regulatory Affairs Specialist I
Johnson & Johnson
11.2022 - 03.2025
R&D Associate
Garden of Life
11.2020 - 10.2022
Supplier Quality Engineering Intern
AbbVie
06.2020 - 08.2020
Bachelor of Science - Interdisciplinary Business, Innovation & Tech
The College of New Jersey