Regulatory Affairs Officer Neutron


Key Responsibilities:
• Responsible for preparing the submission dossier to Ministry of Health and communicating with the principals regarding local regulatory requirements.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Maintaining the medical device license and post marketing report.
• Liaising and negotiating with regulatory authorities.
• Ensuring that quality standards and submission deadlines are met.

Minimum Qualifications:
• Bachelor Degree in Engineering, Scientific, Health Care or related degree in reputable university
• Minimum 2 years of regulatory affairs experience in the pharmaceutical or medical device industry
• Fluent in English (oral and written) and ability in Chinese language will be an added advantage

Tanggung Jawab Pekerjaan :

  • • Responsible for preparing the submission dossier to Ministry of Health and communicating with the principals regarding local regulatory requirements.
  • • Keeping up to date with changes in regulatory legislation and guidelines.
  • • Maintaining the medical device license and post marketing report.
  • • Liaising and negotiating with regulatory authorities.
  • • Ensuring that quality standards and submission deadlines are met.

Syarat Pengalaman :
• Bachelor Degree in Engineering, Scientific, Health Care or related degree in reputable university • Minimum 2 years of regulatory affairs experience in the pharmaceutical or medical device industry • Fluent in English (oral and written) and ability in Chinese language will be an added advantage

Kualifikasi :

  • • Bachelor Degree in Engineering, Scientific, Health Care or related degree in reputable university
  • • Minimum 2 years of regulatory affairs experience in the pharmaceutical or medical device industry
  • • Fluent in English (oral and written) and ability in Chinese language will be an added advantage

Keahlian :

  • • Bachelor Degree in Engineering, Scientific, Health Care or related degree in reputable university
  • • Minimum 2 years of regulatory affairs experience in the pharmaceutical or medical device industry
  • • Fluent in English (oral and written) and ability in Chinese language will be an added advantage

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