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Technical Specialist - SFDA medical devices certifications

SGS Gulf Limited

Posted on May 17, 2020

3 - 8 years Abu Dhabi, Dubai, Sharjah - United Arab Emirates

Bachelor of Science. Any Nationality

Medical, paid Leaves etc, will discuss

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Job Description

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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.


Keywords

Specialist SFDA medical devices certifications

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SGS Gulf Limited

SGS - THE GLOBAL GROUP

SGS is the world's leading Inspection, Verification, Testing and Certification company. We are recognized as the global benchmark for quality and integrity. With more than 80,000 employees, we operate a network of more than 1,650 offices and laboratories around the world.

Our core services can be divided into four categories:

Inspection: our comprehensive range of world-leading inspection and verification services, such as checking the condition and weight of traded goods at transshipment, help you to control quantity and quality, and meet all relevant regulatory requirements across different regions and markets.

Testing: our global network of testing facilities, staffed by knowledgeable and experienced personnel, enable you to reduce risks, shorten time to market and test the quality, safety and performance of your products against relevant health, safety and regulatory standards.

Certification: we enable you to demonstrate that your products, processes, systems or services are compliant with either national or international standards and regulations or customer defined standards, through certification.

Verification: we ensure that products and services comply with global standards and local regulations. Combining global coverage with local knowledge, unrivalled experience and expertise in virtually every industry, SGS covers the entire supply chain from raw materials to final consumption.

Skills and leadership of employees, the expertise of our laboratories, reputation of high professional, integrity and unprejudiced and international network defined the unique status of SGS in the world.

Integrity, transparency and ethical behavior are the core values.

For over 30 years now, SGS operates a network of more than 28 offices and laboratories throughout the Middle East employing over 2,000 full-time staff of 32 different nationalities. SGS branch offices spread throughout the United Arab Emirates, Saudi Arabia, Kuwait, Bahrain, Qatar, Oman, Pakistan, Jordan, Lebanon, Iraq and Djibouti covering wide range of its services

SGS services enable clients to operate in a more sustainable manner by improving quality and productivity, reducing risk, verifying compliance and increasing speed to market.

SGS provides diversified range of services through its below business lines:

- Oil, Gas & Chemicals Services
- Industrial Services
- Agricultural & Mineral Services
- Environmental Services
- Consumer Testing Services
- Governments & Institutions Services
- Systems & Services Certification
- Life Science Services
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Contact

Name/ Designation:
Farid Fatourehchi - HR Manager

Website https://www.sgs.com


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