Technical Specialist - SFDA medical devices certifications

Technical Specialist will be responsible for reviewing the design dossiers of a wide range of Active Medical devices with the aim of determining whether the devices meet the requirements of SFDA guidelines and relevant harmonised standards.
• Medical Devices – knowledge on ISO 13485 and its updates
• support or reject the manufacturers application for CE marking based on the evidence provided.
• To determine whether or not a device has been demonstrated to be safe and effective, meets its intended use and can be awarded certification.
• A broad technical understanding of Active Medical Devices.
• An understanding of companies operating in these spaces and current industry trends
• Knowledge in brands dealing with medical devices and their key roles internationally
• Knowledge in ACTIVE IMPLANTABLES / AIMD / SOFT TISSUE / ELECTRICAL / ELECTRONICS ELECTRO-MECHANICAL / ELECTROMECHANICAL / ELECTRO SURGICAL / ELECTRO MECHANICAL / QA / QUALITY ASSURANCE
• Regulatory affairs, certification requirements for EU and R&D;updates in the industry knowledge
• Knowledge in VASCULAR , knowledge of CLASS 1 / CLASS 2 / CLASS 3 / CLASS 3A / CLASS 3B / CLASS I / CLASS II / CLASS III / STERILES / SURGICAL / INFUSION / BOSTON SCIENTIFIC / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL

Technical Competencies
• Regulatory requirements: Knowledge of the medical device regulatory requirements of the recognizing Regulatory Authority(s) to enable an assessment of the applicability and compliance with such laws, regulations, and standards. Including knowledge of the principles and applications of medical device quality management system requirements, risk management system requirements, etc.
• Medical devices: Knowledge of medical devices and the related manufacturing activities, including:
- their intended use
- types of medical devices including their complexities, technologies, and risk classifications
- safety and risks of medical devices
- processes and technologies used by medical device manufacturers
• Auditing Standards and Techniques: Knowledge of standards and techniques for auditing quality management systems.
• Statistical Analysis: Knowledge of the basic concepts of probability and statistics including mean, median, confidence level and standard deviation as it relates to representative sampling and trend analysis.

• Knowledge of applicable standards for medical devices such as IEC 60601-1 & -2, IEC 61010-1 & -2, ISO ISO 80601 & -2.
• Knowledge on safety electrical testing parameters (both electrical & mechanical), RoHS, EMC.

https://www.naukrigulf.com/technical-specialist-sfda-medical-devices-certifications-jobs-in-dubai-uae-in-sgs-gulf-limited-3-to-8-years-jid-170520000050