Mariceles Mendoza is a highly accomplished and results-oriented leader with over 29 years of expertise in the global medical device industry. Her extensive experience spans Quality Assurance, Regulatory Compliance, Regulatory Affairs, and Operations. Mariceles has a proven track record of guiding companies through market entry while ensuring compliance with FDA, CE, and international standards.

As a recognized expert in design controls and risk management, Mariceles supports R&D teams in strengthening product development. She is adept at navigating complex regulatory landscapes and implementing robust Quality Management Systems (QMS). Her deep understanding of international standards, including FDA regulations, EU MDR, MDSAP, ISO 13485, and ISO 14971, has enabled her to successfully lead organizations through major regulatory transitions.

Mariceles is also known for her leadership in conducting audits and delivering tailored training to enhance inspection readiness. She has effectively remediated FDA 483 observations and warning letters, making her a trusted partner in optimizing quality and compliance. Her regulatory expertise and leadership make her an invaluable asset to any organization seeking to excel in the medical device industry. Her expertise encompasses…

Regulatory Compliance:
o Navigating FDA inspections, Notified Body audits, and addressing regulatory observations (483s, Warning Letters).
o Implementing and maintaining compliance with global regulations (e.g., FDA, EU MDR, MDSAP, ISO 13485).
o Developing and submitting regulatory filings (e.g., PMAs, 510(k)s, Technical Files).
o Conducting regulatory intelligence and gap assessments.

Quality Systems:
o Developing, implementing, and maintaining robust QMS compliant with ISO 13485 and other relevant standards.
o Leading design control and risk management processes.
o Managing CAPA, complaint handling, and change control processes.
o Conducting audits.
o Implementing and managing supplier quality programs.

R&D Support:
o Guiding R&D teams on design controls, risk management, and clinical trial support.

Inspection Readiness:
o Leading inspection readiness activities, including mock inspections and pre-inspection assessments.
o Managing front- and back-room operations for regulatory inspections.

Training & Development:
o Developing and delivering training programs on regulatory requirements, QMS, risk management, and other relevant topics.

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.