QA Consultant - SaMD

Exciting Opportunity for a Risk Management Expert in the Cutting-Edge Field of Medical Device Software

Are you ready to take on a role that challenges and enhances your expertise in risk management within the medical device industry? Join us in revolutionizing radiology informatics by ensuring our software as a medical device (SaMD) products not only meet but exceed the highest standards of safety and effectiveness. This remote contract position offers the flexibility to work from anywhere in Israel, coupled with the chance to influence major projects at a pivotal time in our innovation-driven company.

Key Responsibilities

Develop and implement comprehensive risk management frameworks tailored for SaMD, identifying potential risks and establishing robust control measures.

Collaborate directly with the Director of Quality and integrate closely with teams specializing in clinical informatics to align risk management strategies with business objectives and regulatory compliance.

Lead initiatives to apply standards such as ISO 14971, ISO 13485, and IEC 62304 across product development and lifecycle management.

Proactively analyze and refine risk management processes, identifying gaps and implementing strategic improvements to enhance product safety and effectiveness.

Requirements

Minimum of 5 years of experience in risk management, specifically within the medical device sector, focusing on software solutions.

Expertise in regulatory standards applicable to software as a medical device, with hands-on experience in guiding projects through complex regulatory landscapes.

Background in product development, design quality engineering, R&D, or related fields within the medical device industry.

Strong analytical skills, with the capability to work independently and deliver results in a remote setting.

Excellent communication and collaboration skills, essential for working effectively across multidisciplinary teams.

What We Offer

The opportunity to shape the risk management landscape for next-generation medical devices.

A flexible, remote working environment that supports work-life balance.

Professional development opportunities and potential for contract extension based on performance.