RA Executive

2 months ago


Singapore Clearlab Sg Pte. Ltd. Full time

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)

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