Regulatory Affairs and Service Coordinator
6 months ago
_**Regulatory**_
1. Responsible for all regulatory affairs, regulatory compliance activities and submission of medical device products of the company.
2. Review, prepare, compile and submit all documentations required for medical device submission, establishment license renewal, new devices registration, change notification and special access with media.
3. Work closely with supplier /principle to get the registration documents. To arrange teams, google meet or zoom meeting, periodically if there are issues to speed up process.
4. Work closely with the Notified Body (CAB) (Care certification/ BSI) to approve registration and Change Notification for medical devices.
5. Liase with MDA and Supplier's regulatory personnel and sub-agent to ensure all information, label and other documentation with relevant regulations.
6. To initiate renewal process 1 year in advance.
7. To be in charge to respond to supplier whenever there is any queries.
8. To be incharge to respond to customer /hospital whenever there is any queries related to MDA.
9. Manage reporting to MDA for FSCA, recall and complaint of product if required.
10. To takeover Taibah role (registration of product, change notification, FSCA, complaint,recall) except audit to do together with Taibah. In future, to do it internal and external audit annually without Taibah Company.
11. Involve in GDPMD internal and external audit annually.
12. Involve in supplier and Principle audit anually.
13. Responsible to visit MDA office and go for necessary training if required.
14. Monitor and supervise the regulatory status of all products.
15. Responsible to daily update status of progress in MDA group and weekly update for full report.
16. Stay updated on new and existing MDA regulations via online through website.
17. In future, for new product registration to do CSDT, no need for external consultant (TAIBAH).
- **Service**_
1. Responsible to update schedule of PPM service, Ad hoc and warranty to service team.
2. Responsible to do comprehensive and non-comprehensive contract of service.
3. Key in service report job in excel report.
4. Incharge on document of FSCA, complaint and recall of product.
Pay: RM3,000.00 - RM3,500.00 per month
**Benefits**:
- Free parking
- Health insurance
Schedule:
- Monday to Friday
**Education**:
- Bachelor's (preferred)
**Experience**:
- medical regulatory affairs: 2 years (preferred)
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