Advena Ltd in Malta is looking to recruit a Regulatory Associate
to join their team on a full-time basis. The ideal candidate will be reporting to the Managing Director.
Key purpose of the role:
Responsibilities of the role:
- To provide high quality and reliable service to all Advena Ltd Malta contracted clients;
- Fully support the Managing Director of Advena Ltd Malta and assist the Malta office Regulatory Consultant whilst operating alongside the Business Administrator as required;
- Learn and assimilate the regulatory and quality management requirements for the medical device industry and apply this knowledge to the preparation and drafting of client technical documents and quality procedures;
- Assist in the maintenance of all client files utilising various software packages and standard operating procedures.
Qualifications & Experience:
- To represent the company in a professional and courteous manner;
- To assist in achieving the company growth targets;
- To assist in the preparation of the necessary documents for a medical device, or In-vitro medical device, to be considered compliant within the EU;
- To be able to assist in the preparation of the necessary documentation/procedures for a compliant quality management system to ISO13485:2016;
- Be able to provide regulatory advice and guidance to clients when required;
- Fully understand the responsibilities of client document control; this covers all aspects of client records that involves technical administration, reviewing and tracking of European Authorised Representative client records, in particular, the technical content and certifications;
- Maintenance of the Team Desk, web-based database, this is a business-critical piece of software and it is essential that it is kept up-to-date in every aspect of its operation;
- To assist in the formulating and managing a database of clients and their Product Liability insurance cover, this will over time become a critical piece of information that must record our clients cover and dates of validity;
- Develop a good understanding of Xero (Accounting software) and debt chasing procedures;
- Telephone & office housekeeping duties as requested. These duties will be shared between the Malta office employee;
- Develop a good understanding of the Maltese (MCAA) Registration System and develop a good working relationship with the staff at the relevant Maltese government offices;
- Assist with Certificate of Free Sale (CFS) applications, as and when required;
- Assist with applications for legalised, notarised and apostilled documents, as and when required;
- Any other task related to medical device regulatory conformity and quality management as directed;
- Provide competent cover in the absence of the Managing Director and be available in the event of unannounced audits by regulatory bodies.
Set-up in 1996 by John Adcock, and first registered in 1998 as a UK business, we have completed a multiplicity of consulting projects across the world have actively managed well over 300 contracted clients during our 20 years of service. We employ highly experienced consultants with over 35 years’ experience in regulatory and quality affairs.
- Degree in science, medicine or relate subjects.
- IT skills (Microsoft Office products);
- Interest and possible experience with medical devices, medical equipment, quality systems and regulatory affairs;
- Logical and flexible work attitude, and ability to work on own initiative.