Aevice Health Pte Ltd – Regulatory Affairs Intern (Jan – Jun 2024)

Responsibilities

• Assist, manage and maintain documentation and records necessary for FDA and other regulatory submissions
• Plan meetings and follow up with cross functional teams to ensure timelines are met
• Keep abreast and maintain record of changes in the global regulatory requirements for stakeholders to strategies solutions to meet such changes
• Proactively maintain and update regulatory databases in alignment with regulatory requirements
• Compile and maintain documentation for post-market vigilance in accordance with regulatory requirements.
• Assist Quality Manager on CAPA investigations for customer complaints, recurring non-compliance (NC) and audit non-conformances and implement effective corrective actions if any
• Assist in ad-hoc duties and tasks when assigned

Requirements

• Candidates studying in Biological Sciences, Biomedical Engeering, or in similar fields
• Meticulous in handling sensitive information
• Excellent command of written and spoken English
• Good communication skills to enhance cross-functional activities
• Interest in regulatory affairs pertaining to medical devices
• Past working or internship experience in this field is preferred
• Candidates who cannot commit more than 6 months full-time will not be considered

Learning Outcomes

• Gain a deeper understanding of the regulatory and compliance issues surrounding medical devices to be used in commercial and medical settings
• Exposure to Class II medical devices and global regulatory requirements