We’re on a mission to transform healthcare by connecting scattered medical data to derive insights that enable better patient care. On the cutting edge of medical AI, we partner with top healthcare providers to understand, analyze, and structure medical data. AICS’ solutions are deployed in top healthcare providers around the world. AICS has an agile, start-up environment with great career development opportunities. We invite you to join us and advance medical AI together.
At AICS SG, you will:
Work with a world-class team of engineers and researchers.
Ensure the compliance and quality of a product with machine learning at its core.
Coordinate and communicate activities with external consultants and regulatory bodies.
Develop different skillsets and push boundaries in a dynamic start-up environment.
Responsibilities:
Quality Assurance
Manage and prepare the quality management system’ SOPs, Wis, and forms to ensure compliance with international standards and regulatory requirements.
Manage the software development life-cycle documents, such as reviewing documents, and managing changes with approvals.
Ensure the integrity of all documentation in QMS, so that documents can be accessed easily.
Assist in internal and external audits and inspections.
Manage post-market surveillance activities such as NC, CAPA, complaints, adverse events, and support closure of issues.
Regulatory Affairs
Define regulatory requirements from regulatory bodies in Singapore, Taiwan, China, USA and Europe.
Coordinate with the team members in development, product, and clinical to fulfill the requirements.
Review documentation, analysing for gaps, and taking steps with the team to ensure requirements are met.
Work with consultants / internal teams to register products, and manage change notifications to submit to the regulatory authority, taking charge of the overall timeline.
Ensure that regulatory clearances are obtained in a timely manner in line with the business strategy.
Skills:
Must be able to handle multiple tasks, prioritize and pay close attention to details.
Excellent verbal and written communication skills.
Ability to work independently and be highly motivated in a fast-paced environment.
Qualifications:
Bachelor’s degree in a technical or scientific discipline.
Preferably 1-2 years experience in Quality Assurance or Regulatory related role.
Familiar with and understands Quality and Regulatory standards such as FDA, ISO 13485, ISO 14971, MDR framework and standards, NMPA regulations.
ISO 13485:2016 Internal audit / Lead auditor certified is a plus.
