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ROLE DESCRIPTION
1. MAIN OBJECTIVES OF THE POSITION
l Communicate with product manager to confirm the product name and model.
l Fill out the request form and sent them to Singapore RA.
l Collect necessary documents, compile product standard.
l Select typical samples, get the final confirmation from product manger, then place the sample order for local testing.
l Follow the inspection with the engineer of
l Try to solve all the problem happened during the testing procedure, and get the qualified test report.
l During the reviewing procedure of SFDA, we will have to resolve all the problems concerning product standard or testing report. Sometimes we will need to revise the product standard and re-do testing. RA Specialist should be in change of this.
l Learn the related regulation and technical knowledge.
l Improve English and communicate with manufacturer smoothly.
Major Activities(What is done and how) | End Results(Why it is done) |
p class=MsoNormal style="TEXT-JUSTIFY: inter-ideograph; MARGIN: 0cm 0cm 0pt 54pt; TEXT-INDENT: -18pt; TEXT-ALIGN: justify; tab-stops: list 54.0pt left 8.0cm; mso-list: l1 level1 lfo2">· Compile the product standard · Follow up the test · Submit the registration documents to SFDA · Resolve the all problems during the reviewing of SFDA | p class=MsoNormal style="MARGIN: 0cm 0cm 0pt 54pt; TEXT-INDENT: -18pt; tab-stops: 1.0cm list 54.0pt left 8.0cm; mso-list: l1 level1 lfo2">· Got the registration approval |
3. IMMEDIATE MAJOR CHALLENGES
Communicate with product manager, Regional RA and SFDA officer
4. SKILLS, EXPERIENCE AND QUALIFICATIONS (ELIGIBILITY)
The typical background required to competently perform the responsibilities of the job e.g. the type and depth of training, skills and experience or formal qualifications. These requirements will vary from country to country.
p class=MsoNormal style="MARGIN: 0cm 0cm 0pt; tab-stops: 158.9pt 336.05pt 414.05pt">1. Handle imported MD registration independently. 2. Bachelor degree, major in electronic, mechanics, medical, pharmaceutical, biomedical engineering, medical English, pharmaceutical English or related. 3. Good at oral and written English. 4. To be honest, patient and diligent. |