Caroline Rosset
Regulatory Affairs and Quality Director at iPerf Connecting | Lyon, Auvergne-Rhône-Alpes, France
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Caroline Rosset currently serves as the Regulatory Affairs and Quality Director at iPerf Connecting, a pioneering medtech company dedicated to advancing cardio-respiratory support and thoracic and cardiovascular surgery solutions. In her strategic role, Caroline oversees the development and implementation of regulatory strategies that ensure compliance with international standards such as ISO 13485, facilitating the company's ability to bring innovative medical devices, including ECMO systems, to global markets. Her expertise in regulatory affairs and quality management plays a critical role in navigating complex approval processes, managing design dossiers, and maintaining rigorous adherence to GMP and BPF standards.
A key project under her leadership involved the successful certification of the company's quality management system according to ISO 13485, which not only enhanced product safety and efficacy but also strengthened the company's reputation within the highly regulated medical device industry. Caroline’s deep understanding of biotechnologies, medical device regulations, and validation processes ensures that iPerf Connecting’s solutions meet stringent regulatory requirements, ultimately contributing to improved patient outcomes in cardiopulmonary support.
Her skills in managing regulatory pathways, coupled with her ability to foster cross-functional collaboration, have been instrumental in streamlining product development cycles and ensuring compliance with evolving industry standards. With a strong focus on quality management, Caroline’s leadership supports the company's mission to innovate safely and effectively, providing healthcare professionals with reliable devices designed to prevent severe complications during critical procedures. Her proactive approach and industry expertise position her as a vital driver of iPerf Connecting’s growth and compliance excellence in the medtech landscape.
Regulatory Affairs and Quality Director at iPerf Connecting in May 2022 to Present
EMEA Regulatory Affairs Manager at Integra LifeSciences in January 2020 to May 2022
World Tour Travel - Life Experience at Worldwide in March 2019 to January 2020
Regulatory Affairs and Quality Manager at BIOXIS Pharmaceuticals in January 2015 to March 2019
Senior Regulatory Affairs Consultant at RegDesk in September 2017 to January 2019
Quality and Regulatory Affairs Consultant at HRA Pharma in November 2018 to November 2018
Senior Regulatory Affairs Specialist EMEA, Russia, Kazakhstan at Stryker in February 2014 to December 2014
Regulatory Affairs Specialist at Medicrea in October 2012 to February 2014
Regulatory Affairs Specialist (Reg CMC) at Sanofi Pasteur in January 2012 to October 2012
R&D engineer - Internship at GSK in March 2011 to September 2011
Research assistant quality control: development of analytical assays - Internship at Sanofi Pasteur in January 2010 to September 2010
Research Assistant at Biom'up USA, Inc in September 2008 to September 2009
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Université Paris-Saclay, Master's degree, July 2026
l'ESTBB, Bachelor of Science (B.Sc.), July 2026
Université catholique de l'Ouest, Baccalauréat, July 2026
Lycée Notre Dame (Jura), Baccalauréat, July 2026
Spokane High School, 10th grade, July 2026
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Regulatory Affairs
Affaires réglementaires
Gestion de la qualité
R&D
Regulatory Submissions
Biotechnologie
Pharmaceutical Industry
Medical Devices
Vaccines
GMP
Validation
EMEA
BPF
Dispositif médical
Contrôle qualité
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What is Caroline Rosset email address?
Email Caroline Rosset at [email protected], [email protected] and [email protected]. This email is the most updated Caroline Rosset's email found in 2026.
How to contact Caroline Rosset?
To contact Caroline Rosset send an email to [email protected], [email protected] or [email protected]. (updated on March 25, 2025)
What company does Caroline Rosset work for?
Caroline Rosset works for iPerf Connecting
What is Caroline Rosset's role at iPerf Connecting?
Caroline Rosset is Regulatory Affairs and Quality Director
What is Caroline Rosset's Phone Number?
Caroline Rosset's phone (**) *** *** 280
What industry does Caroline Rosset work in?
Caroline Rosset works in the Medical Devices industry.
Caroline Rosset Email Addresses
Caroline Rosset Phone Numbers
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