Clearlab SG Pte Ltd – RA Executive

Responsibilities: 

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

Requirements:

• Minimum Diploma in any science field
• Minimum 1 year in regulatory related experience in a medical device or GMP related industry 
• Experienced in Optical devices / IVD media fill will be added advantage
• Understanding of EU MDR 2017/245, ISO 13485 requirements
• Understanding of related Regulations and GMP requirements
• Able to use Microsoft Office i.e., MS Excel, MS Words
• Must be able to read, write and communicate fluently in English.
• Technical writing skills
• Results-oriented, meticulous and an initiative-taking collaborator.
• Effective decision-making capabilities