· 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.
- 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 email@example.com