Regulatory Affairs Officer/ Certification Specialist

3 weeks ago


Mid Valley City, Malaysia Yaoyao Malaysia Info Tech Sdn Bhd Full time

**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
- Experience in Cross-Functional working in a matrix organization and have MNC exposure is an added advantage

**Responsibility**
- 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

**Salary**: RM3,500.00 - RM5,000.00 per month

Ability to Commute:

- Mid Valley City (required)

Willingness to travel:

- 75% (preferred)



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