Jobs Support Services Jobs in Saudi Arabia in Saudi Arabia
To build up UL’s Venture Business (Life & Health Sciences) in the Middle East we are looking for a
Technical Reviewer (also acting as Deputy Technical Manager) / Regulatory Affairs Specialist - UL CAB Office Riyadh - Saudi Arabia
UL is approved by the Saudi Food & Drug Authority (SFDA) as a Conformity Assessment Body (CAB) in the Kingdom of Saudi Arabia (Riyadh). UL is responsible for reviewing “Medical Devices Marketing Authorizations (MDMA)” applications in accordance with the Saudi Medical Devices Interim Regulations. These regulations require the Legal Manufacturer to demonstrate compliance with the regulations in one of the 5 GHTF countries: EU (MDD/IVD/AIMD), USA (510(k), PMA, QSR), Canada (SOR/98-282), Japan (JPAL), and Australia (Australian MD Regulations). The Technical Reviewer reviews the documentation and provides the SFDA with a recommendation for MDMA license issue / denial. As Technical Reviewer you help SFDA to protect the Saudi market and ensure that only safe and effective medical devices are imported into KSA. You have direct access to SFDA staff since our UL CAB office is located inside the government building from SFDA.
Position overview:
•Build strong relationship with SFDA through quality of work and effective handling of the reviews to further gain market share of the SFDA/CAB Program and win additional business opportunities from SFDA
•Conducts reviews of MDMA applications and qualifies as Deputy Technical Manager over the medium term
Regular tasks and responsibilities:
•Processes SFDA applications in-line with SFDA / UL CAB Program requirements based upon knowledge and expertise with global market access programs for medical devices
•Participates in SFDA knowledge share forums / monthly MDMA meetings to support development of technical requirements for the reviews
•Participates in or leads (as directed) UL internal meetings to calibrate Technical Reviewers based on SFDA feedback
•Monitors and ensures UL CAB operations workflow and processes remain under control from receiving of application through to SFDA payment
•Ensures as Deputy Technical Manager that Technical Reviewers are competent and provides training as necessary to continuously improve their knowledge and competencies
•Supports in continuous improvement of UL CAB Program Requirements, Processes and Tools for efficient handling of SFDA application from assignment through payment
•Supports in hiring and training of local Technical Reviewers in order to ensure effective use of resources to maximize their potential and thereby achieve the required targets and objectives
•Manages the UL CAB office in Riyadh as Deputy Technical Manager
•Builds strong relationships with local and remote Technical Reviewers, UL Notified Body staff, SFDA/UL CAB Program Manager, Sales, Senior Operations Management, Business Development Management and SFDA staff
Job Details
| Date Posted: | 2016-09-02 |
| Job Location: | Riyadh, Saudi Arabia |
| Job Role: | Support Services |
| Company Industry: | Safety/Environment |
Preferred Candidate
| Career Level: | Mid Career |
Apply Now - Jobs in Saudi Arabia - Support Services Jobs in Saudi Arabia - Search All Jobs
jobs Technical Reviewer / Regulatory Affairs Specialist
Support Services Jobs in Saudi Arabia,وظائف في المملكة العربية السعودية/Jobs In KSA,Support Services jobs Technical Reviewer / Regulatory Affairs Specialist ,Jobs Support Services Technical Reviewer / Regulatory Affairs Specialist ,وظائف السعودية,وظائف الخدمات المساندة فى السعودية,شواغر السعودية,وظائف الخدمات المساندة والدعم بالسعودية,مطلوب للعمل بالسعودية Technical Reviewer / Regulatory Affairs Specialist ,وظائف خالية فى السعودية,مطلوب Technical Reviewer / Regulatory Affairs Specialist للعمل فى السعودية