Aevice Health Pte Ltd – Regulatory Affairs Intern

We are looking for an intelligent and highly motivated talent to manage regulatory matters for our products and technology.

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

• 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

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