Aevice Health is a fast-growing healthcare start-up that develops smart wearable devices, mobile platforms and analytics to improve the lives of patients with chronic respiratory diseases. We are a group of innovators and medical professionals who believe in creating convenient solutions for complex and real problems. At Aevice Health, we invest in people who embrace creativity and enjoy taking ownership of their work. We work in small teams to try new ideas, iterate and move fast to develop products.
Regulatory Affairs Intern (Dec-Jun 2022)
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 for FDA and CE regulatory submission
Conduct research on the regulatory requirement and keep updated on current applicable regulations and standards
Plan meetings and follow up with cross functional teams to ensure timelines are met
Maintain Quality Management System (QMS) in the company by ensuring good documentation practice
Assist Quality Manager on CAPA investigations for customer complaints, recurring non-compliance (NC) and audit non-conformances and implement effective corrective actions
Requirements
Meticulous in handling sensitive information
Excellent command of written and spoken English
Interest in regulatory issues 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 worldwide regulatory requirements
Related Job Searches:
- Company:
Aevice Health Pte Ltd - Designation:
Regulatory Affairs Intern - Profession:
Healthcare / Pharmaceutical / Sports - Industry:
Manufacturing General / Biomedical / Pharmaceutical - Location:
Toa Payoh