Quality Assurance and Regulatory Specialist to AMRA

Who are we?

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 75 employees, operating in the US, European and Asian market, 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.

Job assignments

AMRA is expanding the QARA Department team, and now searches for a Quality. Assurance and Regulatory Specialist. You will be an important part of the team, and work close to the SVP Quality Assurance and Regulatory Affairs.

The department drives and monitors all quality and regulatory related work at AMRA group. You and your colleagues' responsibility are to assure that the company works effectively with continuous improvements and is compliant with all the laws and regulations.

You will be responsible for:

- Provide the organization with expertise and guidance in the applicable regulations, as ISO 13485, MDR, 21CFR 820 (FDA QSR) and other applicable standards.
- Registration fulfillment of our products within all our regions
- Prepare and guide within AMRA regarding future submissions of product within US, EU, or other regions
- Assess and assure the changes and updates of relevant international regulations
- Support process improvement initiatives, and work with procedure updates and development, when needed
- Handling of the AMRA issues reporting and tracking systems


With your experience, you will be the expert in the compliance of the regulations for medical device. You will be an important asset in assuring that all requirements are in place in our QMS. Since the team is small you will be working with quality assurance tasks as well.

Further opportunities in your role:

It is very positive if you have experience in clinical evaluations, interactions with FDA, conducting internal auditing or other skills related to the department responsibilities. We also value if you have experience from other safety critical software development companies.

Depending on your skills and experience the responsibility is further flexible, and together we form the role.

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.

Requirements:

- You have deep knowledge and experience in the regulations for medical device in EU and US, minimum 3-5 years. (ISO13485, MDD/MDR, FDA QSR)
- Bachelor’s degree in a scientific or engineering field
- Experience with medical device product registrations
- You have quality assurance experience from a regulatory environment


You are responsive, thorough, objective, and flexible, and are used to drive the responsibilities you have in a structured and self-organized way, and you like to interact with others and cooperate within teams.

This role is based in Linköping but working part-time remotely can be discussed. For this role it is important that you can communicate clearly in English and Swedish, since we are an international company situated in Sweden.

What do we offer?

We offer a stimulating workplace with varying work tasks, highly knowledgeable colleagues, and plenty of opportunities to make a difference.

You will be involved and take responsibility for everything from the operation of our applications, how we write and test our code, end users experience and everything in between.

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 please feel free to contact Camilla Hahn, SVP Quality Assurance & Regulatory Affairs, camilla.hahn@amramedical.com

or Sarah Lantz, HR, sarah.lantz@amramedical.com

As the process is ongoing, please submit your application as soon as possible but no later then 18/12. We kindly refrain from contact with other recruitment firms in this process.