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Atharv Arora

Angestellt, Regulatory Affairs Intern, Kranus Health GmbH

Fähigkeiten und Kenntnisse

Regulatory Affairs
Quality Management
Medical Device Regulation (MDR)
Information Security Management System
ISO 27001
ISO 13485
Risk Management
DiGA
Technical Documentation Management
Atlassian Jira
Atlassian Confluence
CAPA
RNA & DNA Biology
Molekularbiologie
Zellbiologie
Western Blot
Python
ETL (Extract, transform, load)
Fluorescence microscopy
Confocal Microscopy
Cloning
Sequencing
Project Management
Data Analysis
Microsoft Office
Data visualisation
Antibody Staining
RNAi
Biotechnology
Laboratory
Life sciences
Communication skills
Leadership skills
Team work
Commitment
Adaptability

Werdegang

Berufserfahrung von Atharv Arora

  • Bis heute 11 Monate, seit Juli 2024

    Regulatory Affairs Intern

    Kranus Health GmbH

    • Management and Compliance with ISO standards (27001, 13485) • MDR and Class I DiGA compliance • Creation and Maintenance of technical documentation according to the latest standards • Management of Privacy Policy and T&Cs of the company website and DiGAs • Knowledge of SaMD, IEC 62304, IEC 82304-1 • Preparing and concluding Data Processing Agreements with existing and new Suppliers • Management and Handling of Supplier contracts • Preparation of Post Market Surveillance (PMS) Reports • Risk management

  • 2 Monate, Mai 2024 - Juni 2024

    Regulatory Affairs Working Student

    Kranus Health GmbH

    • Maintenance and Compliance with the ISMS • GDPR Compliance • Handling Atlassian team collaboration (Jira, Confluence) tools Skills: Medical Device Regulation (MDR), ISO Management and Compliance (27001, 13485), ISMS, Quality Management, Technical Documentation, General Data Protection Regulation (GDPR), Corporate Communications, Jira, Confluence

  • 1 Jahr und 11 Monate, Mai 2022 - März 2024

    Wissenschaftliche Hilfskraft

    Ludwig-Maximilians-Universität München

    • Studied effects of interspecific biodiversity on intraspecific genetic diversity in grassland plant species using community genomics approach with focus on species-genetic diversity correlations. • Implemented quality assurance processes and effective organization and documentation techniques for research data. Developed and validated lab procedures. Practical Skills: RNA isolation using different kits - Sigma-Aldrich, Zymo, Roboklon, gel electrophoresis, sequencing.

  • 3 Monate, Juni 2023 - Aug. 2023

    Wissenschaftliche Hilfskraft

    Ludwig-Maximilians-Universität München

    • Managed a short-term project and ensured adherence to laboratory quality standards. • Isolated extracellular vesicles from Pseudomonas for further analysis. Practical Skills: Extracellular vesicles isolation from Pseudomonas, Ultracentrifugation

  • 7 Monate, Juli 2022 - Jan. 2023

    Master Thesis Researcher

    Ludwig-Maximilians-Universität München

    • Established functional tools to identify regulatory regions of sense organs candidate genes in female D. melanogaster genitalia. • Executed a complex research project, involving planning, implementation, and evaluation of results. Developed regulatory-compliant tools, emphasizing adherence to ethical and regulatory standards in genetic research. Practical skills: RNAi mediated gene silencing, Confocal microscopy, qPCR, Primer design, Geneious/CLC genomics workbench, Antibody staining, Infusion cloning

  • 4 Monate, Nov. 2021 - Feb. 2022

    Research Assistant

    Ludwig-Maximilians-Universität München

    • Developed tools to analyze interactions between centriolar proteins PLK-1 and PCMD-1 in the model organism C. elegans. • Assisted in documenting experimental protocols and results while contributing to project planning and execution, enhancing project management and documentation practices. Practical Skills: Gibson cloning, Gel electrophoresis, Primer design, Site-directed mutagenesis, SnapGene, Y2H.

  • 3 Monate, Aug. 2021 - Okt. 2021

    Research Assistant

    Ludwig-Maximilians-Universität München

    • Screening of transgenic expression lines for studying candidate gene expression during ovisensilla development in Drosophila melanogaster. • Executed tasks during research and literature review and contributed to data collection and interpretation. Practical Skills: Fluorescence microscopy, GAL4/UAS Reporter system, Fine dissection.

  • 4 Monate, Feb. 2020 - Mai 2020

    Bachelor's Thesis Researcher

    Sugarcane Breeding Institute, Indian Council of Agricultural Research

    • Evaluated genetic basis of apomixis in plants: Recognition of genes responsible for apomixis. • Applied rigorous quality control measures and ensured accuracy and reliability of experimental data through careful verification. Practical Skills: RNA isolation, DNA isolation cDNA synthesis, Bacterial Transformation, TA Cloning, Gel documentation, RT-PCR, PAGE, Plasmid isolation, CRISPR, Blotting, DNA ligation.

Ausbildung von Atharv Arora

  • 3 Jahre und 10 Monate, Okt. 2020 - Juli 2024

    Molecular and Cellular biology

    Ludwig-Maximilians-Universität München

    Grade: Graduated with a grade of 1.6/5 (First Division) (Highest: 1.0, Lowest: 5.0) Research internships in Developmental and Evolutionary Biology, Molecular Biology, and Genetics. Courses Opted: • Biomolecular Interactions • Mechanism of Animal Development • Computational Biology • Methods of Protein Characterization • Transcriptional Regulation • Human Genomics Activities and societies: Managed and oversaw the successful execution of the welcome events for incoming students in 2022.

  • 2016 - 2020

    Biotechnology

    Amity University

    Grade: Graduated with a grade of 8.4/10 (First Class) (Highest: 10.0, Lowest: 5.0). Courses opted: • Pharmaceutical Biotechnology • Molecular Biology • Immunology • Genomics and Proteomics • Computational Biology • Recombinant DNA Technology • Bioanalytical Techniques • Biochemical Engineering Activities and societies: Class representative of the student council from 2016 to 2020. Member of the core organization committee for workshops by IIT Hyderabad.

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Gut

  • Hindi

    Muttersprache

  • Spanisch

    Grundlagen

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