Elyasmin Boutata, Medical Device QARA Manager

Freelancer profile translated to English.

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Description

I am available to help you bring your products to market according to MDR 2017/745 and also the MDD.

Build your QMS according to ISO 13485 standard.

I have a versatile profile for several types of products, manage your teams and build a strategy that best suits your company and your product.

Languages

French
Native or bilingual
English
Fluent
Arabic
Fluent

Workplace preferences

Can work on-site

Paris (up to 50km)

Microport
Regulatory Expert and R&D Support
HEALTH AND WELLNESS
August 2024 - Today (1 year and 10 months)
Bringing cardiology software and medical devices to market, supporting R&D, and creating or updating technical documents.
MDR Certification Technical File Submission Project Management Certification Audit
Laboratoire Euromedis
QARA Director
HEALTH AND WELLNESS
January 2023 - Today (3 years and 5 months)
Nogent-sur-Oise, France
Direction of the regulatory quality department, MDR certification, supplier audits, QMS update.
ISO Certification MDR Certification Technical File Update Team Management

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Management Consultant