<html> <body> Mariceles Mendoza </body> </html>

Mariceles Mendoza

Sr. Director, Quality and Regulatory Consulting and Education

Mariceles Mendoza brings nearly three decades of expertise to the global medical device industry. She is exceptionally knowledgeable in Quality Assurance, Regulatory Compliance, Regulatory Affairs, and Operations, with a strong background in guiding companies through market entry while adhering to FDA, CE, and international standards.

Mariceles is recognized for her mastery of design controls and risk management, providing crucial support to R&D teams. Her deep understanding of regulations and standards, including FDA, EU MDR, MDSAP, ISO 13485, and ISO 14971, has been instrumental in leading organizations through major regulatory shifts and establishing robust Quality Management Systems (QMS). She also excels in conducting audits and providing customized training to ensure inspection readiness, with a proven track record of successfully addressing FDA 483 observations and warning letters.

Mariceles at a Glance

Audit Expertise

  • EU MDD/EU MDR
  • IVDD/IVDR
  • 21 CFR 820, 803, 806
  • 21 CFR 211
  • ISO 14971
  • ISO 13485
  • ISO 22442 Series
  • MDSAP

QMS Process Expertise

  • PREMARKET
    • Design Control
    • ISO 62366/Human Factors
    • ISO 14971/Risk Management
    • Clinical Evaluation
  • PRODUCTION
    • ISO 14971/Risk Management
    • IEC 62304/Software Validation
    • Change Management
    • Process Validation
    • Production and Process Control
    • Supplier Controls
  • POSTMARKET
    • ISO 14971/Risk Management
    • CAPA
    • Complaint Handling and Medical Device Reporting
    • Supplier Controls
    • Change Management
    • Clinical Evaluation Reports
    • Postmarket Surveillance
    • FDA & NB Remediation

Regulatory Submissions

  • USA, Europe and MDSAP Countries
  • PMA, 510(k)
  • CE Marking - Technical Documentation

Education

  • JD, Universidad de Carabobo, Valencia, Venezuela

Language

  • English, Spanish

Certifications

  • MDSAP Trainer Certification
  • ISO 13485 Lead Auditor Certification

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Mariceles' Areas of Expertise

  • Regulatory – Acted as the inspection lead for FDA and Notified Body inspections and audits, ensuring thorough preparation and effective execution. Additionally, served as the response coordinator for facilities cited with regulatory violations, crafting and submitting comprehensive, timely responses to regulatory agencies to address findings and ensure compliance.
  • Quality Management Systems – Expert in QMS development, process improvement, optimization, and remediation. Skilled in providing strategic project planning and management to align quality systems with business and regulatory objectives, ensuring compliance and operational efficiency.
  • Auditing – As a Lead Auditor for TÜV SÜD, managed the certifications for numerous high-profile medical device clients. While working with leading medical device manufacturers, she supported external regulatory audits and FDA inspection activities by offering expert inspection readiness strategies and providing both frontroom and backroom support.
  • Training – Developed training programs (both classroom-based and online) for BD’s internal auditing program, CAPA, supplier management, and other quality system regulations, including ISO 13485, 21 CFR 820, QSIT, Canadian MDR, Japan’s MHLW, EU MDD and IVDD, and ANVISA.

Highlighted Experience

Mariceles has held key leadership roles at renowned organizations, including Zimmer Biomet, Medtronic, and TÜV SÜD America. In these positions, she led global quality audits, supported regulatory inspections, played a pivotal role in regulatory compliance projects, and provided strategic direction to enhance quality system processes.

Additionally, she conducted due diligence audits for medical device acquisitions and offered consultancy services to support organizations in achieving regulatory and operational excellence.

 

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