Isabela Fonseca Email & Phone Number

São Paulo, Brazil

- Prepare registration, post-registration and renewal dossiers for medical devices with ANVISA.- Support and manage INMETRO, ANATEL and DIMEL certifications.- Prepare and review labeling content.- Support the company's regularization process, including GMP Certification processes and their renewals.- Evaluate the technical and scientific information necessary for regulatory submissions.- Support regulatory inspections (national and international).- Support quality management functions to ensure any process/product changes are in regulatory compliance.- Keep the existing technical documentation of registered products updated to comply with current standards.- Participate in change control committees.

São Paulo, Brazil

- Support the development, communication and implementation of regulatory strategies in support of team objectives and product portfolio execution;- Represent Regulatory Affairs in cross-functional development teams;- Create high quality CMC documentation, applying global CMC regulatory strategies, ensuring technical compliance and regulatory compliance, meeting agreed deadlines and electronic publication requirements;- Participate in project team meetings and provide normative guidance related to CMC to other areas such as Manufacturing, Quality, Quality Control and Technical Development;- Perform the appropriate regulatory pre-assessment of the CRs as measured by the CMC's feedback to the RA.

São Paulo, Brazil

- Management and execution of Field Actions (Field Action) and Corporate Hold. - Complaints management of local and imported products. Assistance to customers with technical questions.- Opening and investigation of Non-Conformities. Review of local procedures versus global procedures.- Support in internal and external audits, such as corporate audits, ANVISA, INVIMA and ISO9001 certifications. - Support to the training area, managing the internal training system and applying on-board training for new employees.

São Paulo, Brazil

Management of the documentation system ensuring that: - All regulatory, corporate and ISO 9001 standard requirements referring to Quality records and documents are met, through GAP Analysis; - Management of the creation, revision and obsolescence of documents through the Document Change Control system. - Initial training and recycling whenever necessary for all applicable employees regarding the Good Documentation Practices (Data Integrity) and the Quality Documents and Records Management System. - Evaluation and review of instruction of use (IFU) and their arts of products manufactured in Brazil and out of Brazil. - Registration of new items in the JDEdwards system (E1).

Briarcliff Manor, New York

Program focused on cultural experience and the English language improvement through continuing education, guaranteeing the physical and psychological well-being of a child, as well as the conception of activities. There was also a lot of internal growth and development of new skills such as flexibility, adaptability in a new culture and communication in a different language. I have been to many states in the US, such as FL, TX, VA, PA, DC, NJ, VT, NV, AZ, CA and others.

Jarinu-Sp

- Respond to internal audits ensuring the quality of each sterile product and all documentation related to it. Daily review of data input and issue of reports and certificates. Preparation and performance of trainings with the operational, technical and QA team.- Process management besides Process Control Supervisor, assisting in the resolution of nonconformities, development of Excel spreadsheets and definition and optimization of process flow.- Management of the Radioprotection department, responsible for the documents of all personnel. Also responsible for the validation and calibration of equipment used in radiation control and QA equipment, such as Geiger, new dosimeter batches and spectrophotometers. - Support customers with dose validation process, following norms by ANVISA (Brazilian Health Regulatory Agency).

Itatiba

Development of classes and dynamics for students of all ages, in addition to organizing the use of the laboratory. Responsible for handling and storage of reagents.

Assistant teacher of Chemistry to High School students, including regular classes and lab classes. Responsible for the laboratory which included preparation of solutions and glassware's cleaning.

Bs Degree

Mba