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Opportunity ID:: SGO-201512230
Type :: Full time
Position Level :: ---
Industry :: Sciences - Medicine
Job Specialization :: Sciences - Biotechnology
City :: Singapore
Description :: Responsible for the management and attend to day-to-day operations of the Company’s business unit
Responsible to ensure smooth daily operations
Inventory management, logistics and budget planning
Handling and setting up logistics for distribution channels of INEX products in various markets
Understand the Payer models, commercial order and delivery arrangements of INEX products in individual markets.
Oversee the workflow for INEX products
Develop, complete and implement the accreditation of INEX Quality Assurance and Quality Management System on INEX’s commercial products
Handle company’s Internal Audit/procurement and advance the company’s policy and procedures for regulatory affairs and compliance
Responsible for product registration processes and documentation
Responsible to develop, implement, monitor and maintain ISO 13485 Quality Management System Certification and CE Certification for CE Marketing.
To implement and enforce company documented Quality Systems and related regulations, policies, guidelines and procedures
Liaise and work closely with HSA and ensure guidelines are met
Requirements :: Diploma or degree in Biomedical science / Biotechnology
At least 2 years’ experience in regulatory related work and relevant experience in an operations role
Knowledge of government contract management and knowledge and experience in organizational effectiveness and operations management implementing best practices.
Knowledge of ISO 9001, ISO 13485, CE Marking, Singapore HSA regulations and Product Licensing Registration
Demonstrated leadership ability
Strong analytical skills
Must be proactive and must be critical thinking/forward thinking and results oriented
Computer literate with excellent Excel/Powerpoint software skills
Lowest Qualification :: Diploma
Closing Date :: 5/5/15, 12:00 AM

IGENE Diagnostics Pte Ltd

Phone :: +65 6773 0698
Address :: 71 Ayer Rajah Crescent #01-22,Singapore 139951
City :: Singapore
State :: Singapore
Country :

Description

Innovations Exchange Pte Ltd (INEX) is a pioneering molecular diagnostic company focused on the research, development, marketing and licensing of innovative technology for the advancement of women, maternal and fetal health. A spinoff from the National University of Singapore (NUS), INEX collaborates with prominent clinical scientists and academic institutions to leverage technologies and revolutionise medicine for better, safer outcomes.