Regulatory Affairs and Service Coordinator

2 weeks ago


Shah Alam, Selangor, Malaysia Eternity Healthcare Sdn Bhd Full time
_
Regulatory_

  • Responsible for all regulatory affairs, regulatory compliance activities and submission of medical device products of the company.
  • 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.
  • 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.
  • Work closely with the Notified Body (CAB) (Care certification/ BSI) to approve registration and Change Notification for medical devices.
  • Liase with MDA and Supplier's regulatory personnel and sub-agent to ensure all information, label and other documentation with relevant regulations.
  • To initiate renewal process 1 year in advance.
  • To be in charge to respond to supplier whenever there is any queries.
  • To be incharge to respond to customer /hospital whenever there is any queries related to MDA.
  • Manage reporting to MDA for FSCA, recall and complaint of product if required.
  • 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.
  • Involve in GDPMD internal and external audit annually.
  • Involve in supplier and Principle audit anually.
  • Responsible to visit MDA office and go for necessary training if required.
  • Monitor and supervise the regulatory status of all products.
  • Responsible to daily update status of progress in MDA group and weekly update for full report.
  • Stay updated on new and existing MDA regulations via online through website.
  • In future, for new product registration to do CSDT, no need for external consultant (TAIBAH).
-
Service_

  • Responsible to update schedule of PPM service, Ad hoc and warranty to service team.
  • Responsible to do comprehensive and non-comprehensive contract of service.
  • Key in service report job in excel report.
  • Incharge on document of FSCA, complaint and recall of product.

Pay:
RM3, 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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