Cristina Santa María Tobías, PhD

Regulatory Affairs | Medical Devices

Madrid, Community of Madrid, Spain

About

Passionate biotechnologist with a strong academic background, holding a PhD in Molecular Biosciences and currently pursuing a Master's degree in the Pharmaceutical Industry. Having a solid background of over 6 years of academic research experience, I have decided to shift my career focus towards the pharmaceutical and biotech industry, where I am eager to apply the knowledge and skills acquired in basic research. My academic journey in life sciences began with the completion of a Bachelor of Biotechnology at the Universitat Autònoma de Barcelona, followed by the successful achievement of a PhD in Molecular Biosciences at the Universidad Autónoma de Madrid. As a dedicated researcher, I cultivated a robust skill set, including strategic planning, analytical thinking, and effective problem solving. Throughout my doctoral thesis, I actively participated in international scientific congresses and published impactful scientific articles, providing me with valuable opportunities to collaborate with international partners and developing verbal and written English skills. In order to gain a comprehensive understanding of the industry on a global scale, I have joined the Master’s in Pharmaceutical and Parapharmaceutical Industry at CESIF. I am enthusiastic about leveraging my research background to navigate the regulatory landscape and contribute meaningfully to the advancement of pharmaceutical initiatives. Detail-oriented and committed, I am driven by a continuous learning mindset and aspire to further develop my career in the field of Medical Device Regulatory Affairs. Let's connect to explore collaborative opportunities in this exciting and evolving industry.

Experience

  • Regulatory Affairs & Post-Market Surveillance at Avizor Eye Care Solutions
    Apr 2024 - Present · 2 yrs 3 mos

    • EU Medical Devices Regulation MDR 2017/745 • Technical Documentation compilation in compliance with MDR • Maintenance of product registries in non-EU countries, especially LATAM • Identification of regulatory requirements for product registration in new markets and development of regulatory strategies in collaboration with other departments • Review and approval of labelling and instructions for use • Post-Market Surveillance (PMS) • Development of Periodic Safety Update Reports (PSUR) • Development of Post-Market Clinical Follow-Up (PMCF) Plan and Reports • Vigilance, reporting of Serious Incidents and Field Safety Corrective Actions (FSCA)

  • Centro de Biología Molecular Severo Ochoa, CBMSO (6 yrs 8 mos)
    • PhD Student
      Jun 2018 - Apr 2023 · 4 yrs 11 mos

      At the Centro de Biología Molecular Severo Ochoa (CBMSO), I worked on my PhD Thesis in the laboratory of Dr María Gómez, studying the “Role of chromatin conformation on transcriptional and post-transcriptional alterations of chromatin-RNAs”. Main lab techniques used: Cell culture, chromatin-enriched RNA isolation and sequencing, NGS analysis, chromatin-RNA immunoprecipitation, immunofluorescence of DNA fibers, fluorescence and confocal microscopy, qPCR and flow cytometry.

    • Researcher
      Sep 2016 - Jun 2018 · 1 yr 10 mos

  • Internship Student at Centro de Biología Molecular Severo Ochoa, CBMSO
    Feb 2016 - Jul 2016 · 6 mos

    At the Centro de Biología Molecular Severo Ochoa (CBMSO), I did my Master Thesis in the laboratory of Dr María Gómez about the “Effect of chromatin configuration on replication initiation and R-loop formation in mammalian cells”. Main lab techniques used: Cell culture, immunofluorescence of DNA fibers, fluorescence and confocal microscopy, qPCR and flow cytometry.

  • Research Scholar at CNRS - Centre national de la recherche scientifique
    Jul 2014 - Sep 2014 · 3 mos

    At the Institut de Génétique Moléculaire de Montpellier (IGMM), I did a practical training in the laboratory of Dr Robert Feil, under the supervision of Dr Sebastien Lalevee. In the context of an Erasmus Training program, I worked on the “Characterization of a novel long non coding RNA at an imprinted domain and its regulation during liver development in the mouse”. Main lab techniques used: RNA extraction from mouse tissues, PCR, qRT-PCR.