Camila C.

Experience

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  Magnamed

  Jan 2014 - Feb 2015

  Engineering Trainee

  During this period I had the opportunity to work with lung ventilation devices, special with the engineering team, projects and certifications. My main activities were related to the European RoHS directive to adapt the manufacturing process to the environmental waste treatment program. In this issues I contacted raw material and services suppliers, revised electronic and mechanical components datasheets in accordance with the RoHS regulation, and helped to develop alternative methods for manufacturing process. Show less

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  Loktal Medical Electronics

  Sept 2015 - Dec 2018

  As technician responsibible my main activities were related to product and processes quality assurance (QA) regarding manufacture of electrosurgery units and their respective accessories. Some examples of the medical devices I worked with are: - Electrosurgical Unit, smoke evacuator, handpiece control, active electrodes, return electrode, suction Coagulator, bipolar and monopolar forceps, cables and adapters for electrosurgical accessories. As a biomedical engineer, I was responsible for the company's regulatory affairs, updating operating procedures, company's legal department, product certifications such as INMETRO regulations and registration with local and international health agencies.

  • Technician responsible

    Jun 2016 - Dec 2018

  • Regulatory affairs / Quality assurance

    Sept 2015 - Dec 2018
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  Passarini Group

  Jan 2019 - Jan 2020

  Consultant (medical devices)

  • Conducting Brazilian GMP audits in international companies (class III and IV Anvisa’s risk classification)• Technical visits to manufacturing sites, for quality and regulatory assurance.• General instructions in Quality Management System (QMS) requirements for manufacturers and distributors of medical devices.• QMS implementation (ISO 13485:2016 and RDC 16: 2013 Good Manufacturing Practices).• General guidance on regulatory issues.

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  Knoell

  Feb 2020 - Aug 2021

  RA manager (medical devices)

  • Attend national (Brazil) and international projects related to regulatory process, strategies, certifications as well as QMS for companies of medical devices.• Business development participation in sales area (B2B), contacting prospects, conducting meetings, presenting services, preparing proposals, Customer Relationships Management CRM feed.• Technical support for creation of proposals considering costumer regulatory strategies.• Conduct trainings related to Brazilian Regulatory scenario, (Regulatory entities, laboratories, Quality assessment) Show less

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  Strattner

  Jan 2022 - Sept 2023

  Regulatory Affairs Analyst SR

  Main activities performed at Strattner- Post-market surveillance of medical devices. - Field action, recalls and urgent field safety warnings.- Handling non-conformities- Internal and supplier qualification audits- Revalidation of Anvisa operating licenses- SaMD Anvisa registration - aid in diagnostic imaging.

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  Nexgeen

  Oct 2023 - now

  RA & QA Manager

  Responsible for regularizing products in the regenerative medicine segment. Quality management and technical responsibility activities.