Catherine Chaudron Email & Phone Number

Toulouse, Occitanie, Fr

Toulouse, Occitanie, France

Toulouse

Provide expertise, leadership and support in all matters relating to domestic and international Regulatory Affairs and Quality Management Systems for medical devices : - Geographical expansion- Life cycle management (including PMS and Vigilance)- Implementation of new standards / regulation (e.g. MDR 2017-745, …)- Clinical and Biological Evaluation process- Risk Analysis-...

Paris, France

Executive Director Regulatory Affairs and Clinical 2015-2018 :Director of Regulatory Affairs and Clinical 2007-2014 :- Develop Regulatory Affairs organization and processes, recruit, train, manage and take responsibility of Regulatory Affairs staff (team of 8 collaborators through an OPEX organization with the support of consultants). Budget responsibility (500 k€)- Provide regulatory leadership across ALLERGAN Global organization (Expertise in Combo &Class III Medical Devices)- Act as the contact person of the legal manufacturer for Health Authorities, and provide support for audits/inspections (ANSM, GMED, PMDA, US FDA, ANVISA, KFDA, CFDA, etc.)- In charge of registration activities (EU, US, Japan, China, Australia, Brazil...) and maintenance of licenses (Portfolio of 450 licenses)- In charge of regulatory compliance for the site and products (notably defined the implementation plan for the European Device Regulation 2017/745)- In charge of clinical evaluation report management (10 CERs) and of their transition to MEDDEV2.7.1, rev. 4.- Responsible for submission and approval of clinical studies in EU (5 studies)- Develop the risk management process according to ISO 14971:2007 and ensure the implementation of its 2012 version in collaboration with QA- Create the PMS process and co-lead PMS activities with QA- Participate to QMS transition to ISO 13485:2016 and co-lead with QA MDSAP program implementation- Initiate improvement of complaint management and the implementation of a "SIGNAL DETECTION" process- Quality auditor

Paris, France

Technical and Commercial Director 2003-2006:- In charge of aesthetic unit- Head of French sales team (8 collaborators)Director of Regulatory and Clinical Affairs 2000-2006:- Create and lead the clinical department (5 clinical investigations: glaucoma implant, IOLs, OVDs)- In charge of WW registrations (EU and International)- In charge of reimbursement activities- Create and implement the change control process - Create and develop regulatory / standard monitoring process- Obtain the CE mark of Juvederm range with Lidocaine (1st range with lidocaine on the market).Manager Regulatory Affairs 1995 – 2000:- Create and lead the regulatory department within the framework of the MDD 93/42/CE implementation (More than 10 CE certifications obtained: LIOs and OVDs- In charge of vigilance process- Interim Resp. pharmacist