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Jobs or company...

RA Project Specialist (1 year contract)

Salary undisclosed
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JOB DESCRIPTION:

JOB PURPOSE

  • To manage, support, strategize and submit for all local MDR submissions, and all other regulatory affairs activities assigned to ensure market access for the devices, smooth business operation, and to mitigate or avoid any regulatory requirement risk.


KEY RESPONSIBILITIES

  • 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.


MINIMUM EDUCATION REQUIRED

  • Diploma or Bachelor degree in any discipline or equivalent

  • Proficient in the use of MS Word, Excel and PowerPoint

  • Good spoken and written of English language

  • Minimum 1 year of relevant working experience in Regulatory Affairs

  • Good working attitude and communication skill.

  • Able to work independently and possess great sense of responsibility, accountability and ownership.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

MD Medical Devices

LOCATION:

Singapore > Singapore : DUO Tower

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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