What services does Rosa Otero-Marrero offer?

Rosa Otero-Marrero offers Regulatory Pathway Assessment, Classification Assessment, Predicate Analysis, Test Strategy, 510(k) Authoring & Submission, RTA / Deficiency Support and other regulatory consulting support depending on project needs.

What pathways does Rosa Otero-Marrero support?

Rosa Otero-Marrero supports 510(k), Post-market and related FDA lifecycle activities.

What specialties does Rosa Otero-Marrero work in?

Rosa Otero-Marrero commonly supports Cardiovascular device areas.

What regions does Rosa Otero-Marrero serve?

Regions served include: United States (FDA), European Union (MDR/IVDR).

How much regulatory experience does Rosa Otero-Marrero have?

Rosa Otero-Marrero has 8+ years in regulatory and quality work.

Rosa Otero-Marrero — 510(k) & Post-market Consultant (Cardiovascular)

Senior Engineer

Highly accomplished Senior Engineer and Project Engineer with over 8 years of experience in the medical device and pharmaceutical industries. Proven expertise in project management, product development, regulatory submissions (510(k), EU Design Dossier), and quality systems. Skilled in leading cross-functional teams, developing and validating test methods, root cause investigations, and process im...

Experience: 8+ years

Expertise & Specializations

Regulatory Pathways

510(k)Post-market

Device Specialties

Cardiovascular

Regions Served

Rosa Otero-Marrero provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Credentials & Recognition

Education & Credentials

Holds a Bachelor of Science in Mechanical Engineering from the University of South Florida, providing a strong foundation in engineering principles critical for medical device development. This academic background is complemented by an Associate of Arts in Engineering, demonstrating a comprehensive understanding of engineering disciplines. Their education equips them with the analytical and problem-solving skills essential for navigating complex regulatory challenges in the medtech industry.

Certifications

PMP® Certification Training Course
Florida Atlantic University

Risk Management BS EN ISO 14971: 2012 Certificate
Emergo by UL

Lean Six Sigma Green Belt Certification
Florida Atlantic University

Design Control Training Certificate
Oriel STAT A MATRIX

Professional Experience

A highly accomplished engineer with extensive experience in the medical device and pharmaceutical sectors, progressing to Senior Engineer roles. Demonstrated success in leading cross-functional teams for product development, regulatory submissions, and process improvements. Proven ability to manage complex projects from concept to commercial launch, including design verification, validation, and risk management. Expertise includes developing and validating test methods for combination products and cardiovascular devices, ensuring compliance with stringent FDA and international regulations.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)Post-market

Device Specialties

Cardiovascular

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.

ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US, EU
Background: 8+ years of regulatory experience.

Cruxi view

With 8 years of experience, Rosa Otero-Marrero is uniquely valuable for medtech companies due to her in-depth regulatory expertise, particularly in FDA regulations and international standards for combination products and cardiovascular devices. Her extensive experience in leading cross-functional teams, developing and validating test methods, and ensuring compliance with stringent regulations makes her an exceptional asset for medtech companies seeking regulatory submissions, product development, and quality systems expertise. Her track record in supporting 510(k) and European Union Design Dossier submissions for CE Mark showcases her ability to navigate complex regulatory challenges. Additionally, her Lean Six Sigma Green Belt certification and expertise in design verification/validation and risk management further solidify her value for medtech companies. Overall, Rosa's comprehensive skills and experience make her an invaluable resource for medtech companies seeking to ensure regulatory compliance and product quality.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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