RA Project Specialist (1 Year Contract) - Part-Time

ESPONSIBILITIES

• Responsible for Singapore and the assigned countries within SEA.
• Work with Global Regulatory Affairs to plan, schedule, and manage the process of preparing, coordinating and submitting regulatory applications to local Regulatory Authority.
• Support local EU MDR regulatory submission and approval.
• Ensure regulatory approvals are obtained for all marketed devices and general management of registration functions are performed in accordance with regulatory guidelines and company internal procedure.
• Proactively monitor, review and manage internal tracking for licenses that are expiring.
• Update and maintain regulatory submissions and approvals in the designated systems / database in accordance to the internal requirements.
• Work with local Supply Chain and Commercial teams to mitigate supply risks.

QUALIFICATIONS

• At least a Diploma/Degree
• Fresh graduate with minimum or no working experience
• Training will be provided
• Proficient in the use of MS Word, Excel and PowerPoint
• Good spoken and written of English language
• Able to work independently and possess great sense of responsibility and accountability