Isamar Carrillo Masso

Isamar Carrillo Masso Email and Phone Number

Quality, Regulatory, and Clinical Trials Manager, Risk Coordinator, and Management Representative @ Afon Technology LTD
Chepstow, GB
Isamar Carrillo Masso's Location
Newbridge, Wales, United Kingdom, United Kingdom
Isamar Carrillo Masso's Contact Details

Isamar Carrillo Masso personal email

About Isamar Carrillo Masso

Summary:• PhD in Complex Systems, Research Methods, and Game Research from Bangor University (UK)• Experience in research and publishing (both as a writer and as editor) • Quality Management for Medical Devices (ISO 13485:2016+A11:2021) and Risk Management (ISO 14971:2019+A11:2021)• Regulatory Affairs Management and Strategy for Medical Devices • CTM and CRA (following GCP, ISO 14155, and international regulations)I am Isamar Carrillo Masso, passionate Medical Device Regulatory specialist, helping your MedTech business innovate while keeping patients safe.

Isamar Carrillo Masso's Current Company Details
Afon Technology LTD

Afon Technology Ltd

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Quality, Regulatory, and Clinical Trials Manager, Risk Coordinator, and Management Representative
Chepstow, GB
Website:
afontechnology.com
Employees:
19
Isamar Carrillo Masso Work Experience Details
  • Afon Technology Ltd
    Quality, Regulatory, And Clinical Trials Manager, Risk Coordinator, And Management Representative
    Afon Technology Ltd
    Chepstow, Gb
    View
  • Afon Technology Ltd
    Qm, Ra, And Ct Manager, Enterprise Risk Coordinator, Prrc, And Management Representative
    Afon Technology Ltd Mar 2019 - Present
    Caldicot, Monmouthshire, 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.
    View
  • Afon Technology Ltd
    Quality Manager, Regulatory Affairs Lead, Mdsap Auditor, And Ctm At Afon Technology
    Afon Technology Ltd Apr 2019 - Sep 2020
    Caldicot, Monmouthshire, Gb
    Orsus Medical went into administration and was acquired by Afon Technology.
    View
  • Orsus Medical
    Quality Manager
    Orsus Medical Jan 2016 - Apr 2019
    QMS, Risk Management, and Regulatory Affairs for a medical device start-up.MDSAP Lead AuditorISO 13485:2016, ISO 14971:2012, MDR:2017 compliance, CE certification, FDA approval.
  • Credent Medical
    Project Manager
    Credent Medical Oct 2014 - Dec 2015
    Project Management. Protocol testing. Grant writing. Work package design and implementation. Risk assessment. Record keeping and documentation.
  • Creo Medical Ltd.
    Medical Device Verification And Validation Testing
    Creo Medical Ltd. Feb 2014 - Dec 2015
    Chepstow, Gb
    Contract work with Creo Medical. Carrying out Medical Device Testing for Verification and Validation Purposes. Work Design. Protocol Testing.
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  • Chinese Services Ltd
    Freelance Translator
    Chinese Services Ltd Nov 2011 - Nov 2015
    Freelance translation and interpreting, combined with video editing assistance for international adverts (USA, Asia and South America markets).
  • Intellect Journals
    Assistant Editor To The Journal Of Gaming And Virtual Worlds
    Intellect Journals Oct 2009 - Jul 2014
    Copy-editing and liaising with authors.
  • University Of Wales, Bangor
    Assistant Lecturer
    University Of Wales, Bangor Oct 2009 - Jul 2013
    Bangor, North Wales, Gb
    Responsible for teaching undergraduate and MA students, dissertation supervision, and co-responsible for evaluation.
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  • College Of Applied Sciences
    Full-Time Lecturer
    College Of Applied Sciences Apr 2009 - Oct 2009
    Subjects:Children's LiteratureIntroduction to LinguisticsPhonetics & Phonology
  • Presto Language School
    Full-Time English Teacher
    Presto Language School Mar 2006 - Dec 2008
    Responsible for teaching students in upper intermediate and advanced levels, writing materials, testing and evaluation.
  • Stationmasters Uk Ltd
    Assistant Manager
    Stationmasters Uk Ltd Jun 2006 - Apr 2007
    Assisted the General Manager, organized work for employees, daily bookkeeping and monthly accounting. Customer service, shipping, import-export.
  • David’S English Center
    Full-Time English Teacher.
    David’S English Center Mar 2005 - Jul 2006
    Responsible for teaching students in all levels, writing materials, curriculum design and teacher training.
  • The Lion King American School
    Head Of English Department.
    The Lion King American School Mar 2004 - Jul 2005
    Responsible for teaching students in all levels, writing and designing teaching materials and evaluations, translating Educational programmes from Chinese into English, Curriculum Design and supervising, hiring and training English and Chinese teachers. Also responsible for organizing cultural events for the school.
  • Berlitz Language Center
    Full-Time English And Spanish Teacher.
    Berlitz Language Center Mar 2004 - Jul 2005
    Responsible for teaching students in all levels, writing and designing teaching materials and evaluations, curriculum design and supervising and training Spanish teachers.
  • “Herzl-Bialik” High School
    Full-Time English Teacher
    “Herzl-Bialik” High School Sep 2002 - Mar 2004
    Responsible for teaching students in all grades and sections, designing materials and evaluations, curriculum design and founder and director of the Reading Club.
  • Universidad Pedagogica Experimental Libertador
    Part-Time Lecturer (As Part Of The Studentship Programme "Beca-Trabajo")
    Universidad Pedagogica Experimental Libertador Oct 2000 - Jul 2003
    Responsible for the English lab, and teaching selected topics as assistant to the Professors in charge.
  • Inlingua Language Center
    Full-Time English Teacher
    Inlingua Language Center Sep 2001 - Sep 2002
    Responsible for teaching the following courses: Conversation, Grammar, Business English and Pronunciation.
  • Encoven Language Institute
    Academic Coordinator
    Encoven Language Institute Jul 2000 - Sep 2001
    In-company English teacher and night shift coordinator. Responsible for evaluations design, teacher supervision, and teacher training
  • Forum Consultants
    Full-Time English Teacher
    Forum Consultants Oct 1998 - Oct 2000
    Responsible for teaching intermediate and advanced levels of English and curriculum design.
  • Escuela Basica “Republica Del Ecuador”
    Full-Time English And Part-Time Mathematics Teacher
    Escuela Basica “Republica Del Ecuador” Sep 1997 - Jul 1998
    Responsible for teaching intermediate and advanced levels of English and curriculum design, as well as Maths for years 7-9.

Isamar Carrillo Masso Skills

Research Teaching Linguistics Literature Lecturing Higher Education Editing University Teaching Translation Esl Curriculum Design English Corpus Linguistics Qualitative Research Training Video Games E Learning Research Design Applied Linguistics Academic Writing Statistics Analysis Project Planning Copy Editing Teacher Training Academia Public Speaking Program Management Writing Project Management Data Analysis Spanish Discourse Analysis Science Sociolinguistics Spss Language Teaching Project Coordination Project Execution Social Sciences Theory Coordination Auditing

Isamar Carrillo Masso Education Details

  • Bangor University
    Bangor University
    Research Methodology And Game Research
  • Pharmaceutical Training International
    Pharmaceutical Training International
    Medical Device Risk Management
  • The Public Health And Safety Organization
    The Public Health And Safety Organization
    Auditing
  • Apm Group
    Apm Group
    Project Management
  • University Of Reading
    University Of Reading
    Applied Linguistics
  • Chung Hua University
    Chung Hua University
    Mandarin Chinese
  • Universidad Pedagógica Experimental Libertador
    Universidad Pedagógica Experimental Libertador
    Literature

Frequently Asked Questions about Isamar Carrillo Masso

What company does Isamar Carrillo Masso work for?

Isamar Carrillo Masso works for Afon Technology Ltd

What is Isamar Carrillo Masso's role at the current company?

Isamar Carrillo Masso's current role is Quality, Regulatory, and Clinical Trials Manager, Risk Coordinator, and Management Representative.

What is Isamar Carrillo Masso's email address?

Isamar Carrillo Masso's email address is is****@****ail.com

What schools did Isamar Carrillo Masso attend?

Isamar Carrillo Masso attended Bangor University, Pharmaceutical Training International, The Public Health And Safety Organization, Apm Group, University Of Reading, Chung Hua University, Universidad Pedagógica Experimental Libertador.

What are some of Isamar Carrillo Masso's interests?

Isamar Carrillo Masso has interest in Social Services, Civil Rights And Social Action, Education, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Arts And Culture, Health.

What skills is Isamar Carrillo Masso known for?

Isamar Carrillo Masso has skills like Research, Teaching, Linguistics, Literature, Lecturing, Higher Education, Editing, University Teaching, Translation, Esl, Curriculum Design, English.

Who are Isamar Carrillo Masso's colleagues?

Isamar Carrillo Masso's colleagues are Dan Fowles, Huw Hopkins, Lisa Griffiths, Brad Love, Sabih Chaudhry, Julia Ryan, Bethany Hodge.

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