Quality Assurance/Regulatory Affairs Specialist to AMRA

Who are we?

AMRA Medical is a ground-breaking international health informatics company at the forefront of medical imaging and precision medicine. The company 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 clinical care.

AMRA has developed a new global standard in body composition analysis with the ability to automatically produce multiple fat and muscle measurements with unrivaled precision and accuracy, from a single whole-body MRI.

We work with the world’s leading pharma companies and hospitals across the globe. Today we are 35+ employees, operating on an international market, with the need to expand further.

Job assignment

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

The QARA team drives and monitors all quality and regulatory related work at AMRA group. The team’s responsibility is to assure that the company works in a smooth and efficient way and is compliant with all the laws and regulations.

Your daily responsibities will include:

- Maintenance of the Quality Management system, to support and nurture a smooth and effective way of working in our organization

- Support the organization in handling of complaints and improvements of our product, to ensure safe and efficient products, as well as compliance to applicable requirements

- Support the organization in risk management of our products

- Collect and compile data on the performance of our products and processes

- Support the organization in maintaining a high level of Good Clinical Practice

- Keeping our current medical device registrations up to date

- Perform internal audits of our organization

- Support and participate in external audits done by customers, our Notified Body, Competent authorities, and FDA

Who are we looking for?

We are looking for a person who wants to join a young, exciting, and growing company with a focus on support to medical research. The role will challenge you to develop your skills further and to grow with us at AMRA Medical. The SVP Quality Assurance and Regulatory Affairs will mentor you, when needed. As Amra is a small enterprise, you will be working with both Quality Assurance and Regulatory affairs in parallel. We are continuously improving our adherence to Good Clinical Practice to maintain a high service level to our medical research customers, therefore GCP will play an important role in your work.

We believe that you have the following skills:

- Communicative

- Willing to learn and further develop your skills

- A good listener and able to understand different perspectives

- Structured and observant on patterns and details

- Responsive and thorough

- Purposeful and have a high integrity when striving for the goal

- Positive and willing to contribute to our business

- University degree in engineering, medicine, or pharma

- Experience from the medical device or clinical research industry

Other beneficial skills:

- earlier experience from QA/RA in the medical device industry, meaning knowledge of the standard ISO 13485, or similar

- experience from Good Clinical Practice in clinical trials

Depending on your skills and experience the responsibility is flexible, and together we form the role. Your personal skills are more important than your professional background.

This is a full-time employement, based in Linköping. Remote work for part of the time can be discussed. It is important that you can communicate clearly in English and Swedish,since we are an international company situated in Sweden.

Application

If you have any questions please feel free to contact Åsa Callenfors, Director of HR, +46 (0) 70 610 12 57, asa.callenfors@amramedical.com.

As the process is ongoing, please submit your application as soon as possible. We kindly refrain from contact with other recruitment firms in this process.