Business Administrator

Advena Ltd in Malta continues to grow and is now looking to recruit an experienced Business Administrator to join their team of regulatory specialists on a full-time basis. 

About Us:
Advena is an expanding medical device consultancy business. We specialize in supporting small to medium-sized medical device manufacturers and start-ups, to achieve EU CE marking and US FDA regulatory compliance.

Job Summary:
The successful candidate will work alongside our existing team of regulatory specialists, primarily on the review and preparation of various types of documentation for submission with the Maltese Competent Authority and with the EU’s Eudamed database. As a key member of our team, you will manage your workload with other team members, while also providing administrative support to others as required. This opportunity will allow you to use your skills to help develop our worldwide client base.

Essential Job Functions:
You may be involved in the following activities as part of your day-to-day responsibilities:

• To represent the company professionally and courteously.
• Client document control; this covers all aspects of client records that involve technical administration, reviewing, and tracking of EU Authorised Representative client records, in particular, the technical content and certifications.
• Maintenance of Team Desk, a web-based database, is a business-critical piece of software, and it must be kept up to date in every aspect of its operation.
• Develop a good understanding of Xero (Accounting software) and debt chasing procedures.
• Develop a good understanding of the medical device registration system and develop a good working relationship with the staff at the Maltese government offices.
• Understand and assist with Certificate of Free Sale (CFS) applications.
• Assist with applications for legalized, notarized, and apostilled documents.
• 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 policies and procedures.

Requirements:

• Excellent IT skills (Microsoft Office products).
• Be able to demonstrate excellent customer service skills.
• Logical and flexible work attitude, and ability to work on own initiative.
• Have good interpersonal and communication skills and be a team player.
• You must have good organizational skills.
• Attention to detail is extremely important as is the ability to work in a fast-paced exciting and deadline-driven environment. 

Rewards:

• Competitive salary.