Carole ROBIN

Having earned a Doctorate in Pharmacy and an MSc in Quality, I have a passion for public healthcare.
Prior experience was working for Japanese, US-based, and French companies dealing with medical devices, drugs, and cells therapy products for over 30 years. As RA International Director in previous experiences, I have developed, implemented, and maintained regulatory strategies and guidance based on international requirements for all classes of medical devices.
I also have experience in Quality in establishing, maintaining ISO13485 (audits, inspections) and in Clinical Research where I was responsible for managing more than 20 international clinical trials.
I have been actively involved in company executive strategy as a Business Board member (over 15 yrs) and member of French (snitem) and European (MedTech Europe) industrial associations,
More recently I was responsible for leading MDR compliance as a Person Responsible for Regulatory Compliance (PRRC) and international registrations.
Today, at CR MED Consulting I am committed to sharing my compliance experience as a Consultant to support healthcare companies, train in Clinical and Regulatory activities (GMED contract teacher) and to participating actively in AFAR, RAPS, and Team-PRRC Associations.

- Member of the Business Board
- Develop, maintain regulatory strategies and product compliance, Technical Documentation (STED) of medical devices according to Medical Device Regulation (MDR), other international registrations (export), current standards, Eudamed process.
- Develop, maintain strategies of the Post Market (PMS Plan & Report, Promotional material, Vigilance (MIR, IMDRF codification), and Clinical Evaluation processes (CEP, CDP & CER); support to Biological Safety Report, usability, risk management, etc.

Registrations, EC Marking, regulatory strategies for the current and new medical devices (class III implantable, etc.) in relation with Competent authorities and Notify Body. MDD and MDR (2017/745)
QMS (ISO13485:2016, MDSAP) and Vigilance management
Clinical Affairs management and support to Reimbursement (MEDDEV 2.7.1 rev 4)
ansm inspection

.Registrations, reimbursement and regulatory strategies in Asia Pacific, Canada, Latin America and EMEA based on International requirements.
.Effective dialogue with Competent regulatory Authorities, Vigilance of Integra product lines (Human Tissue Products (HTP) and Medical Device (MD)).
. Member of the Business Board

Ensure support of the company's business objectives, develop and implement regulatory & reimbursement strategies and guidance in EMEA (Europe, Middle East, Africa). Coordinate all pre- and post- market clinical studies organized on EMEA market for company's products, the EMEA Speakers Bureau

- Member of the Business Board
- Clinical Research Director

- Development process and portfolio management
Set up an Integrated Portfolio Mgmt Process
- Quality & Environment