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.
Responsibilities
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.
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