Vice President Quality Assurance and Regulatory Affairs

Who are we?

AMRA is a ground-breaking international digital health company at the forefront of medical imaging and precision medicine. 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, rapid, whole-body MRI. We work with the world´s leading pharma companies and academic hospitals.

Today we are 55 employees, serving the US, European and Asian markets.

Job Description

As Vice President Quality Assurance and Regulatory Affairs you will oversee AMRA’s Quality Management System and ensure company-wide regulatory compliance. AMRA´s quality standards are focused on both medical device (CE and FDA) and clinical research. You will be responsible for strategic planning pertaining to quality assurance and regulatory affairs, market clearances, and implementation of new regulations with both in-house talent and external consultants.

Specific job responsibilities:

• Developing and maintaining the regulatory strategy and advising other departments on quality and regulatory matters
• In cooperation with the CEO, defining, developing and implementing AMRA´s Quality Management System.
• Communication with competent authorities as well as customers on regulatory issues.
• Promoting awareness about applicable regulatory requirements and quality management system requirements throughout the organization.
• Serving as an integral part of product and service releases.
• Assuming responsibility for labeling of products and services.
• Overseeing the Risk Management Team.
• Recruiting and managing a direct report.

You will be a member of the management team at AMRA, reporting directly to the CEO and you will be based at our head office in Linköping.

What are we looking for?

You have a Master of Science degree or higher within the field of engineering or medical sciences. You have over 5 years of broad experience in the field of Quality Assurance and Regulatory Affairs, and you have experience being part of senior management in a small company.

To succeed in the role, it is important that you have experience with software development and quality management software systems.

This role requires that you have a track record of success with both internal and external audits, including customers and competent authorities. You will be responsible for planning and executing regular audits. You will work regularly with customers and partners, as well as engage with external consultants. Your strong interpersonal and communication skills will ensure efficient and effective interactions.

In addition, you are highly organized, with exceptional attention to detail and accuracy. You naturally take on a leadership role and adapt easily to changing priorities. You can also work effectively within structured systems and tight deadlines, and are comfortable multi-tasking.

Experience in a Part 11-compliant clinical research setting and MDR is a plus.

As we collaborate with colleagues and customers all over the world, fluency in both written and spoken English is a must.

Are you the right candidate? Apply today!

What do we offer?

We offer a stimulating workplace with satisfying work tasks, highly knowledgeable colleagues and opportunities to make a difference. We are a young company that has a strong scientific foundation, now building a worldwide market presence. As part of our team, you will get an opportunity to contribute to a healthier world. We are a growing team of high-performers from around the world. AMRA is a “flat organization” with open dialogue.

Application

If you have any questions about the role, feel free to contact Eric Converse, CEO, +1 215 313 2636, eric.converse@amramedical.com or Klas Themner, COO, +46 (0) 73 362 81 62, klas.themner@amramedical.com. For general questions please contact Sarah Lantz, HR Administrator, +46 (0) 73 910 99 37, sarah.lantz@amramedical.com.

Application deadline: 14-02-2021. Kindly note that this is an ongoing recruitment process and that this position might be filled before the closing date