RA Manager

Posted 01 September 2022
Salary 100-130K
Job type Permanent
DisciplineHealthcare & Clinical
Reference40493
ContactKathleen Zhu

Job description

RA Manager

Responsibilities

· Prepare & submit product registration documentation & other relevant licences’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore

· Review and edit dossier to comply with regulatory requirements

· Notify and update Health Science Authority (HSA) & any other related agencies of any change of particulars or documents related to product registration

· Ensure changes to the approved products are timely submitted to authorities as required

· Ensure and maintain product approvals and licenses, including dealers etc. where applicable

· Maintain product registration record and product registration database to ensure proper documentation and record filing, including maintain the regulatory database in company’s ERP system (MySAP)

· Manage adverse event reporting, report adverse event to HSA and authorities in AP countries within the stipulated timeline

· Support in budget planning and company’s Medium Term Planning

· Maintain the knowledge and awareness of current applicable regulations and standards and industry guidance that impact the company’s compliance.

· Coaching & training of other RA staff including affiliate’s RA

· Any other assignments as given by Management from time to time.

 

Requirements

  • Bachelor’s Degree in medical science or equivalent with at least 6 years of working experience in regulatory affairs or science/ technical role in healthcare industry (R&D, Clinical or other technical functions) and preferably related to in vitro diagnostics medical device products
  • A good understanding of Regulatory framework in AP countries
  • Knowledge of Medical Device Regulation in countries outside APAC, e.g. USA, EU, Japan, etc.
  • Travel requirements: Approximately 20%

 

For more information, please email to kathleen.zhu@cornerstoneglobalpartners.com