Regulatory Affairs Executive/Senior

17 hours ago

Singapore EYRIS Full time $60,000 - $120,000 per year

Essential Duties and Responsibilities:

Regulatory Affairs Responsibilities:

  • Assist in authoring, editing and reviewing of technical documents e.g. medical device verification & validation documents, standard operating procedures, risk management plans and reports for medical devices.
  • Assist in the preparation, review and compilation of technical dossiers for the purpose of new device registrations and submission of change notifications to regulatory bodies.
  • Provide key regulatory inputs to business development team to assist in achieving the company's overall business objectives.
  • Liaise closely and communicate effectively with key stakeholders on regulatory matters to aid in product commercialization.

Quality Assurance Responsibilities:

  • Manage and lead quality assurance team on-site to achieve company quality assurance objectives.
  • Responsible for the upkeep and implementation of the company's Quality Management System (QMS) in accordance to international quality standards e.g. ISO 13485:2016
  • Collaborate with on-site technical team to consolidate and review quality assurance data, conduct trend analysis and implement improvements to the company's QMS.
  • Plan and execute internal and external audits and risk management reviews according to international quality standards.
  • Perform software quality assurance testing prior to medical device release.
  • Evaluate and review customer feedback promptly, implement and conduct quality assurance investigations for product complaints and implement the necessary corrective and preventive actions.

Work Experience Requirements:

  • A minimum of 2 years' experience in Regulatory Affairs/Quality Assurance role.
  • Relevant hands-on experience in software performance testing and functional testing for web applications.
  • Excellent communication skills are required as the incumbent is expected to participate in cross-functional collaboration with different stakeholders.
  • Detail oriented with good organizational skills.

Education Level Requirements:

  • Bachelor's Degree/Diploma in information technology/healthcare related discipline.

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