Thaís Gondar, Msc work email
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Thaís Gondar, Msc personal email
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Do you know what Regulatory Education means? Folow me 👇🏻I make Regulatory Affairs easy to understand for businesses and consumers since 2001. My career has been built in worldwide healthtechs accelerating medical innovations and new product introductions on global markets. I have more than 350 regulatory applications approved in LATAM, Europe and USA. The job itself was the best busines school I could've attended as a young leader. Quality Management Systems installations and remediations. ISO 13485, RDC 665 and MDSAP international inspections and internal audits. INMETRO and ANATEL certification projects for electromedical devices. Post Market Surveillance processes established from scratch. Regulatory strategies for M&As. Process automation and Regulatory Intelligence. They are all projects I led or was involved as team member in the past 23 years.Now all this knowledge is being packed to deliver the best professional development program for my gifted youngest and regulators wannabes at the Regulatory Academy. 🦉💜✨Each training or team building session, each meeting with board members, trade associations and public officers made me understand my main role as a leader: EDUCATE and INFLUENCE. So that is the purpose of my career now as an enterpreneur and CEO. Nothing creates more value for companies and their brands than Quality & Regulatory Compliance. It is essential that managers, enterpreneurs, health professionals, consumers and patients easily understand and follow local and global sanitary regulations for the sake of public health!There is no sustainable society without Regulatory Affairs. Local and global industry need to raise the bar from QARA to QRC asap. So everyone can be finally ESG certified and our civililization is saved. Remember this: the way we use our resources is always a business decision! The planet will be fine without us anyway.Feel free to follow me on other social media and drop a comment to say hello!➡️www.instagram.com/thais.gondar➡️www.instagram.com/regulatory.academy➡️www.youtube.com/@regulatory.academyWould you like to reach me? I will be more than glad to receive an email from you!➡️Professional contact: thaisgondar@gerberagroup.com.br
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Ceo And FounderGerbera GroupSão Paulo, Sp, Br
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Ceo & FounderGerbera Group Apr 2024 - PresentSão Paulo, Brazil
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Managing DirectorGerbera Group Dec 2020 - Apr 2024
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Creator & FounderRegulatory Academy Jun 2022 - PresentPlanet Earth -
Head Of Quality & Regulatory Compliance LatamGetinge Apr 2019 - Jul 2020São Paulo• Reinstallation and remediation of the Quality Management System in LATAM operations, ensuring compliance with all local regulatory standards• Management of regulatory submissions according to product lifecycles portfolio• Management of INMETRO electrical equipments certification and audits on both manufacturing facilities and sales units• Leadership of the regulatory project for Maquet Cardiopulmonary merger by Getinge Group and all involved operating licenses and product registrations• Responsible for the interface with inspectors, regulatory authorities and trade associations• Management of post-market activities, such as adverse events reportability and execution of recalls and field actions• Talent management and reorganization of the entire QRC team across LATAM operations with development planning and career mentoring• Direct report to Vice-President QRC Operations -
On SabbaticalPerdidaça No Rolê! Dec 2017 - Mar 2019 -
Regional Regulatory Affairs Manager LatamJohnson & Johnson Sep 2013 - Nov 2017São Paulo, Brazil• Management of regulatory activities to integrate Synthes into Johnson & Johnson family of companies after acquisition to install Depuy Synthes business unit• Project management to Orthopedics NPIs in all regulated countries in Latin America managing products, milestones, requirements and timelines to deliver regulatory submission plans in line with business needs• Liaison with local, regional and global internal and external stakeholders to deploy timely and high-quality regulatory fillings• Regulatory Intelligence to identify trends on regulations and to continuously monitor competitive landscape providing valuable regulatory insights that can impact the business• Monitoring RA metrics to evaluate if execution of processes is according to planning and• implement corrections• Harmonization and automation of regulatory processes within LATAM, EMEA and ASPAC as per new Regulatory Affairs Lifecycle Innovation department for cost and effectiveness improvements• Managing and providing career couching to direct and indirect regulatory staff• Direct report to Regulatory Affairs Lifecycle Innovation Director LATAMHighlights:• Creator of the Regulatory Priotitization tool to be used by RALI group globally -
Co Founder And PartnerBravo! Ballet Jan 2013 - May 2016São Paulo Area, BrazilBallet studio affiliated to the Royal Academy of Dance that offer ballet classes for children starting at 2 years old up to adult and senior levels, beginners to advanced.Finance Director | Dancer | Coreographer | Dance Instructor | Cultural Producer -
Regulatory Affairs & Quality Assurance ManagerGambro May 2010 - Sep 2013São Paulo - Brazil• Head of Regulatory Affairs, Quality Assurance and Post Market Surveillance• Definition of regulatory strategy driving direction to regulatory applications and sanitary operating licenses for drugs and medical devices• Local installation of the global Quality Management System in accordance with RDC 59• Providing training to Quality teams from manufacturing sites in order to prepare them to be inspected by ANVISA• Supporting manufacturing sites during ANVISA international inspections as per RDC 59 (medical devices) and RDC 17 (drugs)• Management of post-market surveillance actions, monitoring and tracking customer complaints, alerts, recalls and field actions• Representation of the company within trade associations and regulatory authorities towards shaping the regulatory environment and building strong relationships with ANVISA, medical devices industry and other key external stakeholders. • Regulatory Intelligence to identify trends on regulations and to continuously monitor competitive landscape providing valuable regulatory insights that can impact the business• Direct report to Vice-President QA/RA Americas -
Regulatory Affairs & Quality Assurance SupervisorNl Diagnostica Jan 2009 - Apr 2010São Paulo, BrazilManagement of regulatory submissions (product registration and regulatory licenses) related to IVD products and QMS installation. -
Regulatory Affairs SpecialistGe Healthcare Jul 2006 - Mar 2008Regulatory support to all regulated countries in Latin America (Brazil, Mexico, Argentina, Costa Rica, Colombia, Peru, Uruguay, Venezuela and Panama), preparing regulatory submissions and manage tight deadlines according to local regulations -
Medical Device CoordinatorLegaliza Registros & Marcas Jan 2006 - Jul 2006Consulting in Regulatory Affairs by offering regulatory support to the clients, preparing routine regulatory and mediating the contact between the regulatory agency and the clients in Brazil.
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Food CoordinatorLegaliza Registros & Marcas Jul 2001 - Dec 2005Consulting in Regulatory Affairs by offering regulatory support to the clients, preparing routine regulatory and mediating the contact between the regulatory agency and the clients in Brazil.
Thaís Gondar, Msc Skills
Thaís Gondar, Msc Education Details
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Senac São PauloPostgraduate Education Program
Frequently Asked Questions about Thaís Gondar, Msc
What company does Thaís Gondar, Msc work for?
Thaís Gondar, Msc works for Gerbera Group
What is Thaís Gondar, Msc's role at the current company?
Thaís Gondar, Msc's current role is CEO and Founder.
What is Thaís Gondar, Msc's email address?
Thaís Gondar, Msc's email address is th****@****ail.com
What is Thaís Gondar, Msc's direct phone number?
Thaís Gondar, Msc's direct phone number is +1 732-524*****
What schools did Thaís Gondar, Msc attend?
Thaís Gondar, Msc attended Universidade De Brasília, Universidade De Brasília, Senac São Paulo, Universidade De Brasília.
What are some of Thaís Gondar, Msc's interests?
Thaís Gondar, Msc has interest in Yoga And Meditation, Professional Networking, Professional Interests, Cooking, Jogging, Team Work, Technology, Dancing, Literature, Strategic Planning.
What skills is Thaís Gondar, Msc known for?
Thaís Gondar, Msc has skills like Medical Devices, Regulatory Affairs, Iso 13485, Quality System, Quality Auditing, Fda, Regulatory Submissions, Quality Management, Quality Assurance, Healthcare, Sop, Gmp.
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