Job Title
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.
Work with on marketing project and conduct competitor research and identify potential market opportunities for new products.
Support sales efforts by providing insights on regulatory requirements for entering new markets and advising on compliance risks.
Handle diverse operational matters as needed, contributing to the overall efficiency of the regulatory affairs team.
Learning Outcome
1. Gain Practical Experience in Regulatory AffairsDevelop 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 ComplianceAcquire 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 InsightsWork 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
Able to dedicate at least 3 months full time internship
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: $1000 - $1,300 monthly
Related Job Searches:
- Company:
Alcotech Pte Ltd - Designation:
Medical Device Regulatory Affairs Intern - Profession:
Medical / Therapy Services - Industry:
Manufacturing General / Biomedical / Pharmaceutical