Due to continued growth Advena Limited are seeking to add to our team of regulatory specialists, we have a new position available for a person who can meet the criteria outlined below;
Regulatory Associate – 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 intermediate but crucial role 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 Associate, 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.
This exciting opportunity will allow you to use your relevant regulatory expertise to help develop our worldwide client base, in particular, guiding our clients through the transition from MDD/IVD to MDR & IVDR.
Essential Job Functions
You may be involved in the following activities as part of your day to day responsibilities:
- Preparing, reviewing and approving data elements for use in regulatory technical files in accordance with EU requirements for medical devices and IVD’s.
- Providing on-going regulatory advice and guidance to all clients.
- 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.
- Comply with all company policy and procedures.
Requirements (Regulatory Associate)
- Some regulatory experience with a medical devices background is preferred. However this role would suit a university graduate, majoring in bio-mechanical engineering.
- You will preferably have some experience with the requirements of medical device Class I, IIa, IIb and III technical documentation.
- You will be required to compile clinical data, post market information/data for writing up Clinical Evaluations in line with the requirements of the revised MDD Annex X, MEDDEV 2.7/1 Rev 4
- Risk analysis & risk management activities to ISO 14971 and FDA
- Implementation of various standards and directives relevant to compliance to EU Medical Device Directive 93/42/EC and ISO 13485
- Have good interpersonal and communication skills and be a team player.
- Attention to detail is extremely important as is the ability to work in a fast paced exciting and deadline driven environment.
If you have a keen interest in technical documentation and in medical devices and would be interested in a career as a regulatory associate, 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 by 31st August 2020 for those selected for an initial interview, these are currently planned to be held during September 2020.
Please note we are currently not accepting applications via agencies.