Roli Misra , PhD

Experience

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  National Center for Cell Science

  Apr 2006 - Oct 2012

  PhD

  PhDConducted research in the area of eNOS, VEGF and cancer stem cells signalling, with Dr. (Mrs.) V.P. Kale.Managed Lab resources, making decisions and recommendations for foreign purchases of fine chemicals and scientific instruments for the lab.Supervised and trained two M.Sc. student and one Integrated M.Tech student in cell signalling, cell biology, and animal handling.Prepared scientific reports as well as documenting the project status and results to collaborators and government agencies.Created reports from scientific community relevant to research area using commonly available search tools. Show less

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  EPFL (École polytechnique fédérale de Lausanne), ISREC

  Jan 2015 - Jan 2016

  Postdoctoral Scientist

  As a post doc i managed several independent projects and worked in the area of genetic and translational research of lymphomagenesis. One of the study included the study of tumor microenvironment of different grades of lymphomas and the role of T and B cells in it. The study included the single cell sequencing of the patient samples of lymphomas as well as several studies were conducted on lymphoma mouse mouse models.

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  Ludwig institute of Cancer Research

  May 2016 - Dec 2016

  Research Associate

  My project was to elucidate the effect of radiotherapy and cancer immunotherapy on Ovarian cancer Model.

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  Bianchetto Global Life Sciences Consultants Sàrl

  Sept 2019 - Apr 2021

  Regulatory Affairs Consultant

  Regulatory affairs consultant in area of MD. Experience of EU Medical device regulations (EU 2017/745). Experience in EMA ex submission for pre approval (EU as well as Swiss medics).

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  1MED SA

  May 2021 - Apr 2023

  Regulatory Affair Specialist

  Actively involved in the preparation and update of Technical file according to MDR for various classes of Medical devices ( Class I, IIa, IIb and III).Post Market Follow up (PMCF Plan as well as PMCF report).Clinical Evaluation of Medical device according to MDR.Post Market Surveillance- PMS and PSUR for the devices.Good knowledge of MDR2017/745, MDD, IVDR and 510k submissions.Plan, execute and coordinate regulatory activities for the life cycle of the product.Dialogues with notified bodies. Show less

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  Sequana Medical NV

  Apr 2023 - now

  Regulatory Affairs Specialist
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  SCHILLER AG

  Sept 2024 - now

  Regulatory Affairs Manager

  • Managed regulatory affairs for medical devices including blood pressure monitors, cardiac defibrillators, and ECG devices in Europe, USA, MDSAP, China, Japan, and India.• Responsible for regulatory submissions, document maintenance, post-market activities, standard surveillance, and change management.• Achieved compliance with regulatory requirements, ensuring timely approvals and market access for SCHILLER AG's innovative medical devices.