RAQA Specialist - SEA

A multinational medical devices company with APAC headquarters in Singapore is seeking an RAQA Specialist to assist in carrying out the regulatory operations to ensure on time submission and approval in line with product launches strategy in SEA. The RAQA Specialist is also providing support to maintain the local Quality Management System (QMS) in compliance with the corporate global and local regulatory requirements (if any).

Product registration, change / amendment, renewal:

• Support regulatory functions through preparation and compiling of regulatory documents for new registration submission to health authorities.
• Support the product licenses maintenance.
• Regular check on the regulatory submission status on the health authority official website and with distributors/consultants.
• Filling of all related registration documents.
• Support the review of product labelling, IFU and promotional material to ensure compliance with corporate global and local regulatory requirements.

Post Market Vigilance - Complaint, Adverse Event (AE), Field Safety Corrective Action (FSCA), Recall:

• Support in addressing product complaint from customer to manufacturer, monitor the status until closure.
• Assist to report Adverse Event (AE) to Global RA team.
• Assist to report the vigilance activities to health authorities based on the regulation in relevant countries.

Quality Assurance:

• Support to maintain the local Quality Management System (QMS) in compliance with the corporate global and local Good Distribution Practices for Medical Devices (SS620 GDPMDS).
• Assist to perform internal audits to support compliance with applicable corporate global and local SS620 GDPMDS requirements.

Others:

• Prepare and submit regulatory report on a regular/monthly basis.
• Updating Global RAQA Database.
• Any RAQA related tasks and/or projects assigned.

Requirements:

• Bachelor's degree in a scientific or technical discipline and working knowledge of medical device regulation.
• 2-3 years of medical device regulatory submission.
• Experience in registration submission in Singapore.
• Experience in regulatory submission in any SEA countries will be an added advantage.
• Excellent written and verbal communication skills in English.