Rosa Otero-Marrero
MedTech Regulatory & Project Leader | Combination Products | 510(k) & EU MDR | QMS & Validation Expert
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 improvements (Lean Six Sigma Green Belt). Adept at managing design verification/validation, risk management, and transferring designs to manufacturing. Dedicated to ensuring compliance with FDA regulations and international standards for combination products and cardiovascular devices.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
8
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular
Technology Types:
combo_product, samd
Accepting New Clients:
No
Supports Estar:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
