Medical Regulation Affairs Specialist (software)

Are you looking to make a real impact on people’s lives?

Matrix Medika is Israel's leading provider of Healthcare and Medical software development, regulation, and cyber security services for the healthcare industry and we are growing!

We are looking for an excellent Medical Software Regulation affairs specialist with a can-do approach, ambitious, persistent, and highly motivated.

Check if you are the right candidate and apply today:

Responsibilities

·       Create and approve all medical regulatory documents submitted to regulatory authorities (FDA, CE etc.)

·       Act as the point of contact for all regulatory information related to the company’s work for external customers

·       Supervise medical regulatory activities and projects to ensure that documentation in support of premarket submissions to obtain clearance/approval

·       Responsibility for ensuring the quality of products, processes, procedures, and services in accordance with FDA, CE, ISO 13485, and IEC 62304 regulatory requirements

·       Leading Risk Management activities, FMEA, and writing software & Cyber risk files.

Requirements:

• 2+ years of experience in regulatory affairs in the medical devices industry
• Knowledge of:

- Software life cycle for medical devices (risk analysis, SRS etc.) - a must

- FDA 510(k) experience, SAMD- an advantage

- ISO 14971 (Risk Management) requirements

- IEC 62304, Medical Device Software – Software Life Cycle processes

• Knowledge of information security standards and privacy regulations – an advantage
• Highly motivated, self-learner
• Self-starter with the ability to work independently, while also collaborating with cross-functional teams
• Ownership mindset with a logical, methodical approach to prioritize tasks and responsibilities