Regulatory Affairs Department Manager

2 weeks ago

Hanoi, Hanoi, Vietnam Talentnet Full time

RESPONSIBILITIES:

  • Set KPI/KGI and build action plan to achieve KPI/KGI
  • Support the subordinates to set KPI/ KGI and action plan to achieve KPI/KGI
  • Conduct performance appraisal for subordinates and make a consensus in the Department every year.
  • Manage product registration activities including drafting, reviewing, compiling, and maintaining all necessary registration documentation for submissions according to local regulations.
  • Ensure submissions are executed, monitored and accomplished for market clearance in a timely manner.
  • Ensure the new registration certificates are approved and issued when they come to effect.
  • Review and arrange the submission document to local authority to support exhibition and workshop organized by Marketing team.
  • Ensure the license, submitted dossiers and overall process and procedure are complied with the local regulation for temporary import activities.
  • Monitor impact of changing regulations on submission strategies and update to upper management. Compile, prepare, review and submit regulatory submission to related authorities (Ministry of Health, Hanoi Department of Health, Ministry of Trade and Industry and other authorities if required).
  • Evaluate regulatory risks for Medical division, and formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Cooperate with MDDSC to follow up the actions from MoH and other local authorities.
  • Prepare and submit all external and internal RA reports without delay and mistake.
  • Request and follow up other members to submit other reports related to RA on time and without mistake.
  • Based on company's policy of HR development, make plan and conduct staff education and manage subordinates' skill level.
  • Other tasked assigned by Line Managers

REQUIREMENTS:

  • Bachelor degree or above
  • Knowledge in Regulatory affairs on medical devices
  • More than 3 years experience in management role
  • Fluently speaking in English

For more information, please contact:

  • Ms.

Nguyen Thi Ngoc Ly Ext:
142

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