Carolina Silveira

Carolina Silveira Email and Phone Number

Quality and Regularory Affairs (Specialist) @ Coherence Neuro (formerly opto.bio)
New York, NY, US
Carolina Silveira's Location
New York City Metropolitan Area, United States
About Carolina Silveira

Strong technical background in implantable active devices and neural interfaces. Regulatory experience at the UK regulatory authority (Medicines & Healthcare Products Regulatory Agency, MHRA) within the safety and surveillance department (cardiovascular team), working on post-market surveillance as well as assessing clinical investigations (pre-market). Lead and demonstrated advances in medical device research in both industry and academia.

Carolina Silveira's Current Company Details
Coherence Neuro (formerly opto.bio)

Coherence Neuro (Formerly Opto.Bio)

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Quality and Regularory Affairs (Specialist)
New York, NY, US
Carolina Silveira Work Experience Details
  • Coherence Neuro (Formerly Opto.Bio)
    Quality And Regularory Affairs (Specialist)
    Coherence Neuro (Formerly Opto.Bio)
    New York, Ny, Us
  • Medicines And Healthcare Products Regulatory Agency
    Benefit Risk Evaluation Assessor (Senior Executive Officer)
    Medicines And Healthcare Products Regulatory Agency Jun 2023 - Jul 2024
    London Area, United Kingdom
    Specialist medical device areas: cardiovascular (active & non-active, implantable & external devices).- Perform benefit-risk evaluation assessments within my specialist device areas to inform actions that maximize benefit and minimize risk. Review relevant documentation submitted by manufacturers/representatives as part of post-market surveillance activities (risk management documentation, corrective and preventive action (CAPA), health hazard evaluation reports (HHE), etc.)- Post-market safety incidents (adverse incidents, field safety corrective actions (FSCA/FSN)/ recalls), working closely with manufacturers/distributors/authorized representatives to ensure and support completion of corrective actions.- Trending and analysis of post‐market data from different sources for signal detection and investigation.- Technical assessor of device exceptional use (DEU) applications/derogations.- Pre-market: reviewer of clinical investigations (technical assessor), serious adverse event (SAE) reports, and quarterly/annual reports.- Provide technical guidance on my device areas both internally (working closely with the compliance team on investigations) and externally (responding to enquiries from patients, healthcare professionals, and manufacturers).- Working knowledge of the UK MDR 2002, and of relevant ISO standards such as 14971:2019 (risk management for medical devices) and 13485:2016 (quality management systems for medical devices).
  • Medicines And Healthcare Products Regulatory Agency
    Benefit Risk Evaluation Assessor
    Medicines And Healthcare Products Regulatory Agency Apr 2022 - May 2023
    London, England, United Kingdom
    Specialist medical device areas: cardiovascular (active & non-active, implantable & external devices).
  • Medicines And Healthcare Products Regulatory Agency
    Higher Medical Device Specialist
    Medicines And Healthcare Products Regulatory Agency Jul 2021 - Apr 2022
    London, United Kingdom
    Specialist device areas: electrical medical devices and patient monitoring (MEE); contraceptive and wound management devices; surgical instrumentation.
  • Newcastle University
    Phd Researcher
    Newcastle University Oct 2016 - Jul 2021
    Newcastle Upon Tyne, United Kingdom
    - Thesis: A Study on Interfacing with the Peripheral Nervous System for the Development of Sensory Prostheses. My research focused on current challenges related to electrode design, neural decoding, and stimulation protocols in the peripheral nervous system.- Designed and performed 3 acute in-vivo studies in rodents from start to finish (study design, execution, data analysis, and publication).- Studied the compromise between complexity, acuity, and invasiveness of different types of peripheral nerve interfaces (nerve cuffs and intraneural flexible electrodes) through peripheral nerve recording/stimulation.- Developed signal processing techniques and stimulation protocols to improve the information that can be transmitted or received by these interfaces - ENG and EMG signal acquisition, processing and analysis (feature extraction and classification (MATLAB)).- Extensive in vivo surgery experience in rats (e.g. accessing the sciatic nerve, implanting neural interfaces, and exposing muscles to record EMG signals; ex vivo laminactomy practice (spinal cord exposure)).- Recipient of the competitive SAgE Faculty Doctoral Training Award (full scholarship for the duration of the PhD).
  • Newcastle University
    Teaching And Lab Demonstrator
    Newcastle University Feb 2017 - May 2018
    Newcastle Upon Tyne, United Kingdom
    Foundation Year Electrical and Electronics module.
  • Galvani Bioelectronics
    Neural Interface Graduate Engineer
    Galvani Bioelectronics Sep 2018 - Dec 2019
    Stevenage, United Kingdom
    - Worked in the translational research team on the neural interface characterization program - from benchtop testing and rodent method development to testing the medical devices (electrode + implantable pulse generator) in chronic pig studies.- Tested and compared different electrode materials and stimulation parameters (quantification of fiber activation thresholds and charge injection limits, on-nerve ex vivo preparation).- Designed and conducted the electrochemical measurements at implantation/explantation of the devices during chronic studies (in vivo).- Worked with the Verily team to design and perform the electrode characterization method, including accelerated aging, that led to the pre-verification and validation (V&V) testing.- Completed a 40-hour training course on rodent microsurgical and experimental research techniques at the Rene Remi Surgical Skills Centre - The Netherlands, Nov. 2019.- Received a Global Employee Recognition Performance award, Dec. 2019.
  • Dassault Systèmes
    Engineer Intern - Simulia Simpack
    Dassault Systèmes Jan 2016 - Aug 2016
    Fremont, California, United States
    - Worked with the fundamental tools of SIMULIA Simpack, a multi-body system simulation (MBS) software that had been recently incorporated into the SIMULIA brand, and delivered weekly internal training sessions on introductory topics of Simpack for the engineering team.- Made the technical drawings for a mechanical engineering coursebook (UC Santa Barbara) using DraftSight (a 2D CAD software by Dassault Systèmes).
  • Materialise
    Summer Intern
    Materialise Jun 2014 - Jul 2014
    Leuven, Belgium
    - Designed and ran experiments with 3D-printed surgical guides for knee and hip replacement surgery. Experiments included mechanical testing and scanning of 3D models for optimal implant alignment.- Worked within the research, product development, and manufacturing departments.

Carolina Silveira Skills

Matlab Biomedical Engineering Teamwork Programming Microsoft Office Latex Team Motivation Engineering Windows English Html Css Python Project Management Java C++ Pyth Opensim Research Microsoft Excel Team Leadership Rapidminer Leadership Management

Carolina Silveira Education Details

Frequently Asked Questions about Carolina Silveira

What company does Carolina Silveira work for?

Carolina Silveira works for Coherence Neuro (Formerly Opto.bio)

What is Carolina Silveira's role at the current company?

Carolina Silveira's current role is Quality and Regularory Affairs (Specialist).

What schools did Carolina Silveira attend?

Carolina Silveira attended Newcastle University, Katholieke Universiteit Leuven, Universidade De Coimbra.

What skills is Carolina Silveira known for?

Carolina Silveira has skills like Matlab, Biomedical Engineering, Teamwork, Programming, Microsoft Office, Latex, Team Motivation, Engineering, Windows, English, Html, Css.

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