Regulatory Affairs Associate
1 week ago
**About the Position**
**Role**:
- Review, Prepare, compile and submit all documentations required for medicaldevice submissions, license renewal, new device registrations and change notification with relevant regulatory agencies (MDA, NPRA, Sirim)
- Manages and implements internal regulatory tracking / control systems.
- Keeps abreast of regulatory requirement and changes.
- Liaise with regulatory agencies on defined matters.
- Manages Post Market Surveillance activities (reporting of adverse event, FCA, recall to regulatory agency)
- Work closely with Global RA partners to obtain registration documents.
- Participate in monthly/bi-monthly/quarterly regulatory meeting with Global RA partners.
- Establish close interaction with local business team via monthly/bi-monthly/quarterly regulatory meeting.
- Anticipate regulatory obstacles and emerging issues throughout the device registration cycle. Provide solution or escalate if needed to overcome the issue.
Involve in GDPMD internal and external audit annually.
- Evaluate new requirement and provide business impact if any.
- Reviews and approves local labelling to ensure proper process is in place locally.
- Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Bachelor’s degree in Science or related discipline.
- Good knowledge in Malaysia Medical Device Regulation
- Preferred 3 to 5 years of Regulatory Affairs experience in the Medical Device industry
- Good English language and communication skills.
- Experience in cross functional working in a matrix organization.
- Can works independently with general supervision.
**Khim Goh**
**03-27138830**
**Visit our corporate website**:
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