Description

We are looking for an enthusiastic, and passionate new QARA associate (Quality and Regulatory Affairs) to join our team. You will work directly with the Head of QARA.

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 it’s an exciting time to join our team and contribute to AZmed’s mission.

AZmed’s first product, Rayvolve, an AI-based fracture detection software, has been CE-marked (MDR IIa) for over two years, and FDA-cleared.

With 700 partners and counting, AZmed has partners in over 30 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

In the QARA team, the QARA associate will:

• Management of CE marking and 510k of medical devices.

• Support the overall registration strategies outside Europe and US: coordination, ensuring product/QMS compliance, implementation, execution, control, and completion of product registrations.

• Develop and maintain the Quality Management System to ensure compliance with applicable regulations, standards, and the company’s policy.

• Provide continuing regulatory and quality awareness and training.

• Participate in internal and regulatory audits.

• Perform regulatory and standard watch.

• Perform post-market activities (PMS report, complaints, vigilance, etc.), NC, and CAPA process.

• Provide regulatory support to sales and marketing (promotion, communication, opening of countries).

• Assist in developing, maintaining, and implementing policies and processes that enable consistent, effective privacy practices of protected health and employee information.

• Participate in the release of product versions.

Qualifications

• Ideally one to three years of experience in the medical device QARA field.

• Knowledge of the regulatory environment related to medical devices (EU and US regulation)

• Knowledge of the following standards: 13485 and 14971.

• Ability to work in an ambitious and rapidly growing start-up context.

• 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: 62304, 82304, 62366, MDSAP, and FDA regulation for SaMD.

• Star wars fan

• Sports fan

How to Apply

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

• Include this role’s title in the subject

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