Regulatory Affiars Executive

Concordia International Co.,Ltd

Concordia International Limited we first incorporated in Myanmar in 1994 to provide sales of Engineering & Medical Equipment, Material Testing Equipment, Environmental Testing Equipment, Laboratory Equipment, Multimedia Equipment and the main activities have developed into import, distribution, technical support, after sales service and maintenance of these products in various specialties.

Hlaing,  Yangon   09 September 2019
Job Reference: MJ1559701557475

Duties and Responsibilities

  • Prepare complete dossier for submission of Medical Devices' New and renewal IR
  • Supervise submissions for new and renewals
  • Liaising closely with regulatory authorities and updating of regulatory documents from                                                                         product owner for any change if necessary
  • Reporting any adverse events and FSCAs to the authority
  • Review product database and FDA certificates
  • Prepare adequate RA education and training to other department associates
  • Ad hoc duties assigned by management

Required Qualification

  • B.Pharm Degree Holder
  • At least one year experience in regulatory affairs of medical devices
  • Well knowledge in using Microsoft outlook, excel and word
  • Fair in 4 skill English

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