Description

We are looking for an enthusiastic, and passionate apprentice to join our QARA (Quality and Regulatory Affairs) team. You will be directly managed by the QARA associate.

Why join AZmed?

You will work with developers, data scientists, and doctors, on a daily basis. We are going through a fast growth period, so itʼs an exciting time to join our team and contribute to AZmed’s mission.

AZmedʼs first product, Rayvolve, an AI-based fracture detection software, has been CE-marked MDR IIa) for five years, and FDA-cleared.

With 1000 partners and counting, AZmed has partners in over 40 countries offering the possibility of deploying solutions at scale and used by thousands of physicians around the globe.

You will have a complete QARA apprenticeship in the field of Software as a Medical device that integrates artificial intelligence.

Responsibilities

The apprentice’s main mission will be the establishment of a registry and global regulatory registration strategy including regulatory gaps, deadlines, obligations of actors, and fees to obtain the market authorization for the opening of new countries.

As part of the QARA team, the apprentice will also:

• Participate in the preparation of technical files for the opening of new countries.

• Participate in quality insurance activities (eg.: process creation, complaint management, NC/CAPA management, post-market survey, software validation, supplier management, change control management)

• Participate in the development and maintenance of the company’s QMS.

• Participate in regulatory and standard surveys

• Participate and prepare audits with competent authorities

Qualifications

• M1/M2 in Medical Devices

• Knowledge of the medical device industry and interest in QARA

• Fluent in written English

• Rigorous and organized

• Autonomous

• Good communication, and collaborative skills

Bonus points

• Knowledge of the following standards and regulations is a plus: 2017/745, 13485, ISO 14971, MDSAP, FDA regulation for SaMD, 21CFR Part 820.

Sounds like a perfect match? Email us at jobs@azmed.co !

• Include this role’s title in the subject

• Include your resumé / LinkedIn … whatever works best for us to get to know you