Quality and Regulatory affairs


[Internship/Apprenticeship]

Description

We're looking for an outstanding Quality and Regulatory Affairs intern to join AZmed.
Doctors waste a lot of time looking for fractures in X-rays.
At AZmed, you will help to automate this detection process, for doctors to spend most of their time on life-threatening exams. You will get hands-on experience implementing Quality and Regulatory Management systems to improve the radiologists' workflow and assess a real impact for the radiologist and therefore, the patient.


Why joining AZmed ?

We are an enthusiastic, passionate and hardworking team looking for a similarly minded QARA intern. You will work in collaboration with the whole AZmed team and a QARA maanager 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 the AZmed's mission. You will have a huge impact on the company’s future success and have the possibility to become full-time.

AZmed is among the 1% of companies selected to be accelerated by the Techstars Paris program. Techstars is the world largest entrepreneurs’ network that helps them succeed. You will thus work in a great startup atmosphere (masterclasses, workshops, social events etc).

AZmed’s first product, Rayvolve, an AI-based fracture detection software, has recently been CE-marked, so you will work on the first French CE-marked deep learning software in radiology.


Responsibilities

Evolving in a dynamic and promising context, you will collaborate with the QARA manager in defining the Quality and Regulatory strategy of AZmed according to the regulatory and normative context.

- Contribute to the QMS and its modification
- Preparation of the audits
- Contribute to the Ressource Management process
- Management of NCs and CAPAs
- Contribute of the risk management process and define the products classification
- Ensure the regulatory watch and animate relations with the regulatory authorities
- Animate the team training on the QMS system


Required Skills

- Good knowledge of the normative and regulatory environment remated to medical devices (Regulation 2017/45, ISO 13485)
- English writting skills
- Strong communication skills & collaborative mindset
- Want to improve healthcare and have a positive impact


Bonus points

- Previous experiences in medical devices
- Japanese culture fan
- Star wars/Simpson fan
- Sports fan


Other information

- Apprenticeship possible
- Starting ASAP
- Based in Paris 2nd


If this sounds exciting to you, we want to meet you! Shoot an email to jobs@azmed.co !