Our Team

Education and Professional Membership

• BSc Chemistry
• Member of the Spanish Cosmetic Association
• Regulatory Qualified Person certified by DIDA

Profile

A seasoned Chemist, Maria brings a wealth of knowledge and expertise from two decades of experience in the regulatory field. Maria has extensive experience as an EU Authorized Representative and a proficient Person Responsible for Regulatory Compliance (PRRC). Maria provides strategic regulatory guidance and operational support to organisations across diverse industries.

Maria can provide the following support services:

• UK, US and EU device registration actor
• Specialist in Regulatory Pathways for EU, US and UK for Medical devices and cosmetics products.
• EU MDR / In Vitro Diagnostic Regulation IVDR transition advisory (Classification and Regulations)
• 510k and PMA regulatory pa. Q- Submissions.
• Medical device / IVDR files remediation/update
• Submissions worldwide for Medical devices in Europe (Notified Bodies, HA), US, Australia, South America (In each HA)
• Medical Devices Technical File writing (EU MDR / IVDR / 510K)
• MDR/IVDR /CRF Compliance
• Development of Clinical Evaluation Plan and Report, Performance Evaluation Plan and Report; PMCF; Post-Marketing Surveillance Plan and Report.
• Technical Documentation assembling
• Labelling advice

Current work at JREG

Maria is our resident subject matter expert on substance based medical devices and borderline medical devices with focus on products that overlap with pharmaceutical and cosmetic regulations