Requirements- Fluent English & Bahasa Malaysia language and communication skills
Bachelor Degree in any related discipline- At least 1 year relevant working experience
Have Regulatory Affairs working experience background is a must
- Good knowledge in Sirim, ST, MCMC, KPDNHEP and other related certifications bodies
Experienced in electronic products category is preferred- Able to work independently with general supervision
Candidate must be willing to travel locally within Malaysia (Warehouse Inspection, Sending samples for testing, etc)
- Experience in Cross-Functional working in a matrix organization and have MNC exposure is an added advantage
Review, prepare, compile and submit all documentations required for Home Appliances & Electrical devices submissions, license renewal, new device registrations and change notification, import permit with relevant regulatory agencies (SIRIM, ST, MCMC, KPDNHEP)
- Manages and implements internal regulatory tracking / control systems
Liaise with regulatory agencies on defined matters- Work closely with Global colleagues to obtain registration documents
May be involved in cross functional assignments
- Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area
Any other related duties may be assigned from time to time- Responsible in uploading and compiling regulatory and quality assurance documents
Establish close interaction with local business team via weekly / monthly regulatory meeting
- Keeps abreast of regulatory requirement and changes
Manages Post Market Surveillance- Anticipate regulatory obstacles and emerging issues throughout the device registration cycle. Provide solution or escalate if needed to overcome the issue
Evaluate new requirement and provide business impact if any
- Reviews and approves local labeling to ensure proper access is in place locally
Job Type: Full-time
Pay: RM3,
- 00 - RM5,000.00 per month
Willingness to travel:
* 75% (Preferred)
