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
- ISO 13485 Lead Auditor
- Minimum 1 year in regulatory related experience in a medical device or GMP related industry
- Experienced in Optical devices / IVD media fill
- 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
- Able to converse in another language (Chinese, Malay, Indian)
