RA Executive

at  CLEARLAB SG PTE LTD

REQUIREMENTS:

• Diploma in any science field.
• At least 2 years of experience in regulatory affairs within the medical device or GMP-related industry.
• Knowledge of EU MDR 2017/245 and ISO 13485 requirements.
• Proficient in Microsoft Office (MS Excel, MS Word).
• Fluent in English, both verbal and written.

• Prepare and compile all necessary application and technical documentation for all marketed countries, including EU CE, US FDA, and Singapore HSA for Clearlab Group.
• Conduct and compile Post-Market Surveillance activities, including Adverse Event Reporting, Product Recall, and Periodic Safety Update Reports (PSUR) for Clearlab Group.
• Update, monitor, and maintain Product Registration, Trademark License Listing, and other related licenses for marketed countries.
• Update and maintain Technical Files, CSDT, and any relevant Product Registration Technical Files.
• Update and maintain Artworks and Packaging Labels, including Device Labels and IFU for all marketed regions.
• Support QMS activities to ensure compliance with regulatory requirements.
• Assist in internal and external audits and perform other ad-hoc duties as needed.Support the Document Control Centre as required.