Medical Device Regulatory Affairs Intern

Role Overview

As a Medical Device Regulatory Affairs Intern, you will support our regulatory affairs team in managing the regulatory processes for medical devices. You will assist in preparing documentation, conducting research, and ensuring compliance with regulatory requirements. This internship provides a valuable opportunity to learn about regulatory affairs in the medical device industry and gain practical experience in a supportive environment.

About us

Alcotech is a company that specialises in Drug testing, Alcohol testing, Infectious Disease Kits, and Medical Device Regulatory Affairs.

Interns will have the opportunity to:

• Gain exposure to regulatory processes and requirements in a professional and dynamic setting.
• Hands-on experience in medical device regulatory affairs and compliance.
• Work with experienced professionals and gain insights into the medical device industry.

The day-to-day activities

• Assist in preparing and reviewing regulatory submissions, including pre-market applications, technical files, and compliance reports.
• Conduct research on regulatory requirements and guidelines for different markets to support submission strategies and compliance.
• Maintain and organize regulatory documentation and track submission status and deadlines.
• Assist in monitoring and reporting on the performance of medical devices in the market to ensure ongoing compliance.
• Identify and mitigate the risks associated with the unregulated sale of medical devices on online platforms. Work closely with regulatory bodies, marketplace operators, and internal teams to ensure that all devices sold online comply with applicable laws and regulations.
• Handle diverse operational matters as needed, contributing to the overall efficiency of the regulatory affairs team.

Learning Outcome

1. Gain Practical Experience in Regulatory Affairs

Develop hands-on experience in preparing and reviewing regulatory submissions, maintaining documentation, and ensuring compliance with industry standards. Learn to navigate regulatory processes in the medical device sector.

2. Understand Regulatory Requirements and Compliance

Acquire knowledge of regulatory guidelines and requirements for different markets. Conduct research to support compliance strategies and understand how to manage the regulatory landscape effectively.

3. Enhance Professional Skills and Industry Insights

Work closely with experienced professionals to gain valuable insights into the medical device industry. Improve your organizational, research, and communication skills while contributing to the efficiency of the regulatory affairs team.

Requirements

• Highly organized and detail-oriented
• Proactive team player, able to take charge and follow-through
• Ability to work independently and as part of a team

Work Environment

Office working environment

Working hours are Monday - Friday 9am - 6pm

Our office address is

25 Bukit Batok crescent

#09-13 The Elitist

Singapore 658066

Salary: $800 - $1,300 monthly