Caroline Oliveira Email and Phone Number
Caroline Oliveira personal email
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I am a Senior Regulatory Affairs Specialist at Medtronic, with a rich background spanning over six years of experience in Regulatory Affairs. Beginning my journey in 2018 at Medtronic, in Brazil, I transitioned from the QMS department to roles in Regulatory Affairs, gaining expertise in national and international regulatory frameworks.My expertise includes international registrations across Latin America and strategic initiatives such as CE mark removals in support in audits. I specialized in implantable devices (EU Class IIb and III, FDA Class II), managing regulatory strategy, submissions, and project functions.This journey culminated in my relocation to North Haven, USA, as part of Medtronic's global operations, where I continue to work with implantable devices, assuming additional responsibilities for maintaining a smooth implementation of MDR changes on RA perspective and other strategic projects.I excel in maintaining regulatory compliance through focused and detailed oriented evaluations on change management processes, ensuring product integrity, safety and availability to the customer. My adaptability, leadership, communication, problem-solving, and attention to detail drive success in navigating evolving regulatory landscapes and driving sustainable outcomes.I am always open to new challenges, in the regulatory field, eager to acquire new knowledge that aligns with my career objectives and ensures patient safety and well-being to alleviate pain, restore health, and extend life.
Medtronic
View- Website:
- medtronic.com
- Employees:
- 75896
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Sr. Regulatory Affairs SpecialistMedtronic Nov 2022 - Present- Specialist on sustaining process at Medtronic Wound Closure division including Brazil and US manufacturing facilities. - Development of global regulatory strategies covering US, EU & international regions for change controls and new product development. - Lead the preparation of regulatory submissions for product changes as required for ANVISA classes I, II, III and IV. - Support preparation of submissions in LATAM. - Support product development teams in interpreting and applying applicable standards, regulation, and guidance for Polysuture products/process. - Review labeling, training, promotional and advertising material. - Elaboration and revision of local regulatory SOPs as well as recommend changes for regulatory compliance. - Professional interaction with regulatory agencies as ANVISA and BSI. - Knowledge of EU MDD, EU MDR, ANVISA and LATAM requirements. - Experience working with EU class 3 devices. - Experience representing RA in inspections/audits either performed internally or by Notified Bodies.- Provide mentorship, training, and support to junior RA collaborators. - Ability to problem solve within challenging environments. -
Regulatory Affairs SpecialistMedtronic May 2020 - Nov 2022 -
Regulatory Affairs AssociateMedtronic Oct 2018 - May 2020 -
Qms AssistantMedtronic Jan 2018 - Sep 2018São Sebastião Do Paraíso E Região, Brasil -
Estagiário De Análises ClínicasSanta Casa De Misericórdia De São Sebastião Do Paraíso 2016 - 2017São Sebastião Do Paraíso E Região, Brasil
Caroline Oliveira Skills
Caroline Oliveira Education Details
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Biomedical Sciences, General
Frequently Asked Questions about Caroline Oliveira
What company does Caroline Oliveira work for?
Caroline Oliveira works for Medtronic
What is Caroline Oliveira's role at the current company?
Caroline Oliveira's current role is Sr. Regulatory Affairs Specialist | Surgical Innovations | General Surgical Technologies | Medtronic.
What is Caroline Oliveira's email address?
Caroline Oliveira's email address is ca****@****ail.com
What schools did Caroline Oliveira attend?
Caroline Oliveira attended Fundace, Universidade De Franca.
What skills is Caroline Oliveira known for?
Caroline Oliveira has skills like English.
Who are Caroline Oliveira's colleagues?
Caroline Oliveira's colleagues are Nicoletta Campodonico, Deanna Darrett, Amy Duke, Frank Pennetta, Pooja Arora, Natán Mañón De Los Santos, Nicole Merrells.
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