Offer summary

Qualifications:

Degree in medicine with specialization, At least 4 years of experience, Basic knowledge of EU MDR and ISO standards, Skilled in using MS Office and digital tools.

Key responsibilities:

Analyze clinical data for device validation

Monitor real-world device performance and compliance

Job description

THE COMPANY

Join a Growing Organization Making Its Mark in France.

Are you ready to be part of an exciting new chapter in the medical devices industry? This company is a well-established and respected global organization known for its expertise in quality assurance and regulatory compliance. With a reputation for excellence, they are now expanding their footprint by creating a brand-new business in France a thrilling opportunity to be part of something from the ground up.

This company is dedicated to working as a true partner with its clients, fostering relationships built on trust, expertise, and collaboration.

Their mission goes beyond compliance; they aim to empower their clients to deliver safe and innovative healthcare products to the market efficiently.

THE OPPORTUNITY

Are you a dedicated medical professional looking to expand your expertise and make a meaningful impact on the medical device industry? This is your chance to step into a dynamic freelance opportunity as a Clinical Specialist with a renowned player in the Testing, Inspection, and Certification (TIC) industry.

As a Clinical Specialist, you'll play a pivotal role in ensuring

the safety, performance, and regulatory compliance of cutting-edge medical devices under the Medical Device

Regulation (MDR). This is more than a jobits a chance to leverage your clinical expertise to contribute to advancements in healthcare technology.

KEY RESPONSIBILITIES

Evaluate Clinical Data: Analyze data provided by manufacturers to validate the safety and effectiveness of medical devices.
Assess Post-Market Data: Monitor real-world device performance to ensure ongoing compliance and address emerging risks.
Risk Management Oversight: Review and refine clinical risk assessments to align with regulatory standards.
Support Technical Documentation: Ensure all clinical evidence meets the stringent requirements of the MDR.
Ensure Regulatory Compliance: Contribute to critical device approval decisions by thoroughly assessing clinical aspects.

QUALIFICATIONS

Medically Qualified: A degree in medicine with a specialization and active clinical practice.
Experienced: At least 4 years of hands-on experience in the use of medical devices, pathology, and treatment alternatives.
Regulation-Savvy: Basic knowledge of EU MDR 2017/745, ISO 14155, and ISO 14971 is a plus.
Detail-Oriented: Skilled in preparing clear reports an records with high attention to detail.
Tech-Savvy: Comfortable using MS Office and digital tools for analysis and reporting.
Fluent in English: Excellent communication skills to collaborate effectively across teams.