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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 8
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States (Florida)
- **Availability:** available_now
- **Certifications:** PMP® Certification Training Course, Risk Management BS EN ISO 14971: 2012 Certificate, Lean Six Sigma Green Belt Certification, Design Control Training Certificate
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Rosa Otero-Marrero stands out for her unique combination of FDA experience, device expertise, technical skills, and approach. Her in-depth knowledge of FDA regulations and international standards, coupled with her extensive experience in leading cross-functional teams and ensuring compliance, makes her an exceptional asset for medtech companies seeking regulatory submissions, product development, and quality systems expertise. Her ability to navigate complex regulatory challenges and her track record of successful submissions further solidify her value, making her a valuable partner for medtech companies seeking to ensure regulatory compliance and product quality.
- **Ideal projects:** Rosa Otero-Marrero is ideally suited for medtech clients seeking regulatory expertise in combination products and cardiovascular devices. Her extensive experience working with startups, SMEs, and large medtech companies on complex projects from concept to commercial launch makes her an excellent fit for projects involving design verification, validation, and risk management. Companies seeking to submit 510(k) and De Novo applications, particularly those in the cardiovascular device space, would greatly benefit from Rosa's expertise. Her ability to lead cross-functional teams and ensure regulatory compliance also makes her an excellent partner for international expansion projects or those requiring compliance with FDA and international regulations.
- **Confidence score:** 80/100
- **Last analyzed:** Mon Jan 05 2026 15:36:48 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, international
- **Specialties:** cardiovascular, general-hospital, software-samd
- **Device panels:** cardiovascular
- **Regulatory pathways:** 510k, post_market
- **Type:** independent
- **Years of experience:** 8
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States (Florida)
- **Availability:** available_now
- **Certifications:** PMP® Certification Training Course, Risk Management BS EN ISO 14971: 2012 Certificate, Lean Six Sigma Green Belt Certification, Design Control Training Certificate
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Rosa Otero-Marrero stands out for her unique combination of FDA experience, device expertise, technical skills, and approach. Her in-depth knowledge of FDA regulations and international standards, coupled with her extensive experience in leading cross-functional teams and ensuring compliance, makes her an exceptional asset for medtech companies seeking regulatory submissions, product development, and quality systems expertise. Her ability to navigate complex regulatory challenges and her track record of successful submissions further solidify her value, making her a valuable partner for medtech companies seeking to ensure regulatory compliance and product quality.
- **Ideal projects:** Rosa Otero-Marrero is ideally suited for medtech clients seeking regulatory expertise in combination products and cardiovascular devices. Her extensive experience working with startups, SMEs, and large medtech companies on complex projects from concept to commercial launch makes her an excellent fit for projects involving design verification, validation, and risk management. Companies seeking to submit 510(k) and De Novo applications, particularly those in the cardiovascular device space, would greatly benefit from Rosa's expertise. Her ability to lead cross-functional teams and ensure regulatory compliance also makes her an excellent partner for international expansion projects or those requiring compliance with FDA and international regulations.
- **Confidence score:** 80/100
- **Last analyzed:** Mon Jan 05 2026 15:36:48 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, international
- **Specialties:** cardiovascular, general-hospital, software-samd
- **Device panels:** cardiovascular
- **Regulatory pathways:** 510k, post_market
Key Highlights
- 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
- Rosa Otero-Marrero stands out for her unique combination of FDA experience, device expertise, technical skills, and approach. Her in-depth knowledge of FDA regulations and international standards, coupled with her extensive experience in leading cross-functional teams and ensuring compliance, makes her an exceptional asset for medtech companies seeking regulatory submissions, product development, and quality systems expertise. Her ability to navigate complex regulatory challenges and her track r
Certifications & Trust Signals
- 8 years experience
Buyer Snapshot
Best for
- Rosa Otero-Marrero is ideally suited for medtech clients seeking regulatory expertise in combination products and cardiovascular devices. Her extensive experience working with startups, SMEs, and large medtech companies on complex projects from concept to commercial launch makes her an excellent fit for projects involving design verification, validation, and risk management. Companies seeking to s
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k)
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
