Finding Jobs In Indonesia - Job Agency Indonesia

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Finding Jobs In Indonesia - Job Agency Indonesia

Company Logo
(Head of Division/ Chief level)
(Biotechnologies)
Sumatera, Indonesia
Jan 18, 2018 - Advertise Date
Apr 18, 2018 - Expired Date

Company Descriptions

Our client helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need. 

Their scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world.

Requirements
  • Good Knowledge and understanding on IVD medical device regulatory framework of Indonesia Ministry of Health and ASEAN Medical Device Directive (AMMD).
  • Diploma/Degree in a science-based discipline (Biomedical, Pharmaceutical etc.) or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered
  • Relevant RA/QA experience in IVD medical devices for 1-2 years is preferred
  • Strong communication and computer software skills.
  • Ability to liaise with multiple functions and meet deadlines. 
  • Good document management skills in archiving, tracking and maintenance of electronic and paper regulatory files
  • Analytical, meticulous and good Interpersonal skills
Responsibilities

Position Summary:

Coordinates and prepares regulatory documentation package for registration submission and fulfilment of customer’s regulatory support requests

 

Jobs Functions:

  1. Compile dossiers/regulatory documentation for product registration, tenders, change notifications and renewals.
  2. Maintain registration status information of products in Company’s GPRS system:  new registration requests, renewals, change notification, approvals.
  3. Post-Market Approval Surveillance: Support Adverse Events Reporting, Field Safety Notification/Corrective Action Reporting to local health authority.
Length of Experience
:
6 - 8 years
Employment Type
:
Permanent
Work Location
:
DKI Jakarta, Indonesia
Reporting To
:
Regulatory & Compliance Manager, SEA
Anastasia Irawati -

Contributor

Anastasia Irawati - (Consultant)

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