Business Segment
Healthcare Quality
About Us
GE Healthcare's Healthcare Systems business provides a wide range of technologies and services for clinicians and healthcare administrators that can help caregivers improve the consistency, quality and efficiency of patient care everywhere. These technologies help provide fast, non-invasive ways for doctors to see broken bones, diagnose trauma cases in the ER, view the heart and its function, or identify the early stages of cancers or brain disorders. With X-ray, digital mammography, CT, MR and Molecular Imaging technologies, GE creates industry-leading products that allow clinicians to see inside the human body more clearly than ever. In addition, with efforts in ultrasound, ECG, bone densitometry, patient monitoring, interventional imaging, incubators and infant warmers, respiratory care, anesthesia management and a wide range of technologies and services for clinicians and healthcare administrators, GE's Healthcare Systems business enables clinicians to provide better care for millions of patients every day - from wellness check ups to advanced diagnostics to life-saving treatment. Quality: GE Healthcare is committed to Quality and Compliance in every decision we make & every action we take, believing that this benefits patients, customers, and our business. We support Quality and Compliance in all that we do through two fundamentals: -The Spirit ... the integrity of our products, processes and actions -The Letter ... the adherence to the rules to make sure our products and practices are in compliance with applicable laws and regulations. What makes GE Healthcare different? Leadership & Learning - Learning is more than a classroom activity. It's how we come together to embrace change, develop skills for change, and get energized. GE spends more than $1 billion annually in employee development and leadership training. What makes GE Healthcare different? High-integrity business practices - Ours is an invigorating, high performance environment that emphasizes high-integrity business practices. We seek to lead in workplace and marketplace integrity by respecting the human rights of everyone touched by our business, and by enforcing legal and financial compliance.
Role Summary/Purpose
The Regulatory Affairs Specialist - Region may be involved in Pre-market duties or both. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket support. He/she ensures accurate and optimal submissions of regulatory reports that meet the requirements of the region or country.
Essential Responsibilities
- File and maintain regulatory deliverables - Analyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies - Support regulatory inspections as required - Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes. Premarket - Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions - Complete specific country testing and work with Product RA; arrange for test devices and support as needed. - Partner with Product RA to review advertising and promotion materials for country compliance and approve these as required. - Act as liaison with external regulatory reviewers to gain rapid approval of submissions. - Work with Product RA for countries with license expiration requirements; establish plan and deliverables for timely submission for renewal of license Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goa
Job Details
| Date Posted: | 2013-09-13 |
| Job Location: | Riyadh, Saudi Arabia |
| Job Role: | Other |
| Company Industry: | Other |
Preferred Candidate
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