Isamar Carrillo Masso
Qm, Ra, and Ct Manager, Enterprise Risk Coordinator, Prrc, and Management Representative @Afon Technology Ltd
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WORK HISTORY
Qm, Ra, and Ct Manager, Enterprise Risk Coordinator, Prrc, and Management Representative @Afon Technology Ltd
Caldicot, GB
Quality, Regulatory, and Clinical Trials Manager, Enterprise Risk Coordinator, Person Responsible for Regulatory Compliance, and Management Representative. Duties:To develop, implement, and maintain quality management systems for medical device R&D.To Verify and Validate devices prior to testing. CT Protocol and clinical documentation writing.Regulatory submissions.To create documentation for QMS ad QSR compliance.To manage documentation for regulatory submissions. ISO 13485, ISO 14971 certification and compliance, CE certification, FDA approval.To develop a global regulatory strategy.To ensure the company complies with ISO 13485:2016, ISO 14971:2012, and the new MDR. To ensure that MD risk is taken into account in every key company process and milestone.Lead auditor. To conduct regulatory and compliance audits as per ISO 13485 and the MDSAP.
EDUCATION
University of Reading
MA, Applied Linguistics
The Public Health and Safety Organization
CQI IRCA Certified QMS Lead Auditor, Auditing
Universidad Pedagógica Experimental Libertador
Bachelor of Education - BEd, Linguistics; TEFL, Education, Literature
Pharmaceutical Training International
Cerificate of Continuing Professional Development, Medical Device Risk Management
APM Group
PRINCE2 Foundation, Project Management
Bangor University
PhD, Research Methodology and Game Research
Chung Hua University
Advanced Chinese Diploma, Mandarin Chinese
SKILLS
ABOUT ISAMAR CARRILLO MASSO
Summary:• PhD in Complex Systems, Research Methods, and Game Research from Bangor University (UK)• Experience in peer-reviewed research, writing, and publishing (both as a writer and as editor) • Quality Management for Medical Devices (ISO 13485:2016+A11:2021; QMSR) and Device Risk Management (ISO 14971:2019+A11:2021)• Global Regulatory Affairs Management and Strategy for Medical Devices • Clinical Trials Manager (GCP; ISO 14155:2020+A11:2024)• Enterprise Risk Management (ISO Provide internal training to team members on the aboveI am Isamar Carrillo Masso, passionate Medical Device Regulatory specialist, helping your MedTech business innovate while keeping patients safe.
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