Regulatory Specialist to the QARA Department

Who we are?

AMRA is a ground-breaking international digital health company at the forefront of medical imaging and precision medicine. AMRA was founded in 2010 as a spin-off of Linköping University, Sweden, with the aim to support transformative care and vital decision-making from clinical research to health and wellness. Today we are 60 employees and are operating in the US, European and Asian markets, with the need to expand further.

The company has developed a new global standard in body composition assessment, the ability to automatically produce multiple fat and muscle biomarkers with unrivaled precision and accuracy, as well as contextual disease insights - all from a single whole-body MRI.

We work with the world's leading pharma companies and academic hospitals in the world.

Job assignments

At AMRA, you will be an important part of the small Quality Assurance and Regulatory Affairs (QARA) department, and work together with the SVP QARA. The department drives and monitors the quality and regulatory related work at AMRA, in order to assure that the company works effective with continuous improvements, and is compliant with all the laws, regulations and other requirements that is needed for all the applicable and planned markets. We need to expand the team, that today consists of a mix of AMRA personnel and external consultants.

Responsibilities

The role is new, and the responsibility is flexible depending on your experience. With your experience, you will be the expert in the compliance of the regulations for medical device. Your will be an important asset in assuring that all requirements are in place in our QMS, and also in the work with follow up that the QMS is established throughout our organization. You will work together with other departments in order to support for instance their application of the requirements in their SOPs, and you are used to drive and cooperate in similar tasks. Since the team is small you will be working with quality assurance tasks as well. Together we will form the role and the responsibility.

Who are we looking for?

We are looking for a person who wants to join a young, exciting, and growing company. The role will challenge you to develop your skills further and to grow with us at AMRA Medical. The ideal candidate should have 3-5 years’ experience in relevant industries and at least a Bachelor’s Degree. responsive

You are responsive, thorough, objective and flexible, and are used to drive the responsibilities you have in a structured and self organized way.

Other requirements

- You have deep knowledge and experience in the regulations for medical device in EU and US
- You have quality assurance experience from a regulatory environment
- You have knowledge of the standard ISO 13485, or similar
- You have experience from risk management
- Experience in or authorization as quality auditor is a plus


You must be fluent in English with the ability to write and converse clearly and effectively.

What do we offer?

We offer a stimulating workplace with varying work tasks, highly knowledgeable colleagues and opportunities to influence. We are a young company that has a strong scientific foundation, now building a worldwide market presence. As part of our team you get the opportunity to contribute to a healthier world.

Application

If you have any questions, feel free to contact Camilla Hahn, SVP Quality Assurance & Regulatory Affairs, camilla.hahn@amramedical.com or Lina Boozon Ekberg, HR, lina.boozon.ekberg@amramedical.com

As the process is ongoing, please submit your application as soon as possible. The selection process will start after the 10th of January.