Global Quality & Regulatory Executive
A distinguished Global Quality & Regulatory Executive with over 41 years of extensive experience in the MedTech industry, specializing in FDA, EU MDR, and ISO standards. Proven expertise in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class II/III approvals. Adept at architecting post-market surveillance and compliance strategies, buildin...
Experience: 41+ years
Submissions: 5 510(k)
Jose Ayala provides regulatory consulting services to clients in:
Holds a Master of Science in Clinical Nutrition from Maryland University of Integrative Health and a Bachelor of Science in Biology from the University of Puerto Rico. This strong scientific foundation, combined with specialized nutritional knowledge, provides a unique interdisciplinary perspective valuable for understanding complex medical devices and their impact on patient health. Further enhances their ability to interpret clinical data and contribute to the regulatory strategy for a wide range of medical products.
Active member of the Regulatory Affairs Professionals Society (RAPS), demonstrating a commitment to professional development and engagement within the regulatory affairs community. This membership signifies access to current industry best practices and a network of esteemed regulatory professionals.
A seasoned Global Quality & Regulatory Executive with over 40 years of extensive experience in the MedTech industry, demonstrating a profound understanding of global regulatory landscapes. Proven expertise in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class II/III approvals across diverse markets including FDA, EU MDR, and APAC. Adept at architecting post-market surveillance and compliance strategies, building audit-ready QMS, and leading cross-functional teams to accelerate global market access. Trusted SME in MedTech investment risk and regulatory due diligence, empowering investors and startups to successfully navigate high-stakes global regulations.
A distinguished Global Quality & Regulatory Executive with over 41 years of extensive experience in the MedTech industry, specializing in FDA, EU MDR, and ISO standards. Proven expertise in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class...
With 41 years of experience in the medtech industry, this consultant specializes in providing comprehensive regulatory expertise, particularly in FDA compliance, EU MDR, and ISO standards. Their extensive experience in driving compliance for Ophthalmic, CRM, and combination products, with a remarkable track record of 130+ Class II/III approvals, demonstrates their ability to navigate complex regulatory landscapes. Their expertise in architecting post-market surveillance and compliance strategies, building audit-ready QMS, and leading cross-functional teams to accelerate global market access showcases their value in ensuring regulatory readiness. Additionally, their proficiency in managing QMS modernization, digital transformation projects, and conducting rigorous audits further establishes their reputation as a trusted regulatory professional. Furthermore, their experience as a trusted Subject Matter Expert (SME) in MedTech investment risk and regulatory due diligence highlights their ability to empower investors and startups to successfully navigate high-stakes global regulations.
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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