Due to our continued expansion in Malta, Advena Limited are seeking to add a Regulatory Intern to our team of regulatory specialists, this is an exciting opportunity for an individual who has an interest in medical devices and new medical technology, we offer ‘on the job’ training to the successful applicant who over time would progress to Regulatory Associate as a steppingstone into consultancy.
We invite applications from students in their final year or those who have recently graduated.
- Gain an understanding of Regulation (EU) 2017/745 & (EU) 2017/746.
- Basic technical documentation reviews.
- Regulatory administration.
- Liaising with external regulatory authorities to ensure approvals are obtained in line with project schedules.
- Performing all activities in compliance with relevant Quality Systems standards and specifically with ISO 13485.
Applications should be majoring in Engineering or comparable/similar disciplines.
Regulatory Intern – Medical Devices
Office Based in Swatar, Malta
Advena Limited is essentially two companies; Advena Limited in the UK and Advena Limited in Malta. Both companies are expanding medical device consultancy business, the UK business primarily has a client base from within the EU (including the UK), while our office in Malta has a client base who are located outside the EU. As a group we specialise in supporting small to medium sized medical device manufacturers and start-ups, to achieve regulatory compliance and CE Mark their medical device products.
This is an exciting time to join Advena, in this entry level role that has plenty of potential, within our small team of regulatory specialists, to primarily work on assisting with the preparation of technical documentation and files for submission for audit by Notified Bodies. However, there are also business administration duties, including our quality management system, that must be carried out that underpin our activities.
As Regulatory Intern, you will be an integral member of our team, you will be guided by senior team members, providing you with the requisite support and guidance, enabling you to gain valuable experience to grow and develop with Advena.
If you have a keen interest in technical documentation and in medical devices and would be interested in a career in Regulatory Compliance, with the long-term goal of becoming a consultant and can demonstrate an understanding of the criteria outlined here, we would love to hear from you.
Applications must be submitted to Mr Anthony Kirby by email to firstname.lastname@example.org including a copy of your CV. by 30th June 2021, for those selected for an initial interview, these are currently planned to be held mid-July.