Who am I?

TECHNICAL SKILLS

Senior freelance consultant in medical devices and in vitro diagnostic medical devices.

PhD in Immunology and Cancer, with 11 years of experience in the medical device industry in Regulatory Affairs, R&D and Operations. Consultant and trainer with experience both in the implementation of the Quality Management System (QMS) that complies with ISO 13485, MDR/IVDR or FDA, as well as in the creation and development of the Design History File (DHF), clinical evaluation, PMS and Technical File (TF) for evaluation by Notified Bodies. Over 3 years of experience helping specifically software companies guide their development according to medical device industry standards.

 EDUCATION

2019 - Master Online “Farmacia Industrial Aplicada y Registro de Medicamentos” | CESIF (Spain)

2014 - Diploma of Clinical Research Assistant, Formatis Paris, France

2003 – 2004 - Ph.D in Immunology and Cancer | Paris XI University, Institut Gustave Roussy (France)

1999 – 2002 - Bachelor of Science in Applied biology | Kingston University (UK)

 

COURSES AND CERTIFICATIONS

2022 Course  - Technical documentation required for IVDR, BSI

2022 Certificate - Internal Auditor ISO19011 , BSI

2022 Course  - Cybersecurity in medical device, TUV

LANGUAGES

•        English Fluent

•        French Native

•        Spanish Fluent

REGULATORY AFFAIRS

•        MDR and IVDR

•        MDR and IVDR software (IEC62304, IEC82304)

•        DHF, Risk analysis, Process validation, Sterility process validation, GSPR, technical file and clinical file redaction.

•        Post-Market surveillance and clinical follow-up.

•        MEDDEV 2.7/1, MEDDEV 2.7/4, MEDDEV 2.12/2, EN ISO 14155:2020, MDCG 2020-3, MDCG 2022-4, MDCG-2020-7, MDCG-2020-8

QUALITY ASSURANCE

•        Life Cycle Management

•        QMS implementation according to ISO13485 / MDR / IVDR / FDA 21CFR

•        Certified Internal auditor, ISO 19011.

•        ISO 22716, ISO 15189

•        Risk analysis evaluation (FMEA, 6M fishbone (Ishikawa) diagrams, Factor Tree Analysis, 5 WHY).

CLINICAL EXPERTISE

•        CRA, clinical research assistant, responsible for the redaction Clinical Evaluation Report (class IIa and class III) in Skin Tech Pharma Group.

R&D ACTIVITY

•        Medical device development Class II & III (injectable products).

•        Cosmetic formulation (skin care, peelings products).

VALIDATION ACTIVIES

•        Analytical assay development & Validation of analytical procedures according to ICH Q2.

•        Manufacturing process validation (IQ, OQ, PQ)

MANUFACTURING ACTIVITIES for Medical Device class III & II and IVD (In Vitro Diagnostic Medical Device)

•        Scale up.

•        Validation of industrial fabrication processes.

•        LEAN manufacturing.

•        Life cycle management of Reagents (continuous improvement of manufacturing process, alternative suppliers)

TECHNICAL EXPERTISE

•        Immunology and immunological assays development.

•        PCR based IVDR and related analytical assays.

•        Protein precipitation and solubilization.

•        Hydrogel development for intradermal usage in human ( eg:  RRS HA Long Lasting).

•        Software development.

WORK EXPERIENCE

  • Ambit Iberia | Consultoría regulatoria y de calidad en sector para el sector Life Science

    01/2022 -09/2025 - Senior Medical Device Consultant

    I have served dozens of companies in the MDR, IVDR, and software sectors

    •        Implementation of Quality Management System (QMS) compliant for ISO13485, MDR, IVDR , ISO15189 and FDA.

    •        Helping companies to create appropriate Design History File (DHF)

    •        Creating Technical file for NB submission

    •        Writing Clinical and PMS documents

    •        Trainer on Software as Medical Device, QMS, EUDAMED, PMS

    •        Lead Auditor ISO13485 for internal audits as well as external audits for suppliers

  • QIAstat-Dx - QIAGEN

    01/2021 – 01/2022 - Life Cycle Management Reagent Department, Senior Scientist

    •        Life cycle improvements, change evaluation of a Point of Care IVD Real-time PCR system of infectious diseases.

    •        LEAN manufacturing in a clean room environment.

    •        Analytical assay development for raw material in-coming inspection or intermediate preparation in-process control (IPC).

    •        Supplier & Raw material qualification.

    •        Scale up of reagents manufacturing processes.

  • SKIN TECH PHARMA GROUP

    01/2019 – 12/2020 - R&D Department, R&D head of department

    •        Supervising the R&D team (4 formulists+1 researcher) Cosmetic development & medical devices class III and class IIa.

  • SKIN TECH PHARMA GROUP

    08/2014 – 01/2019 - Scientific Department, Researcher

    Development of cross-linked hyaluronic acid for aesthetic applications as filler and intraarticular application for arthritis treatment.

  • SKIN TECH PHARMA GROUP

    08/2014 – 01/2019 - Regulatory Affairs Department,  Clinical Research Associate

    •        Responsible of presentation of 2 technical files for CE certification Class III MDD.

    •        Update of the clinical file (including Post-Market Clinical Follow up) and risk analysis and essential requirements of existing CE Medical Devices (1 class III and 1 class IIa).

  • Academic researcher

    04/2007 – 09/2013 - Post-Doctoral Position (Public Research Institute)

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The regulatory route

is not that difficult

if you are well advised.