Experience from regulatory affairs in USA/Canada and want to improve patien

RaySearch develops innovative software solutions to improve cancer care. Over 2,600 clinics in more than 65 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. Headquarter is in central Stockholm and the company has subsidiaries in the US, Europe and Asia. Today we are more than 400 employees with a common vision in improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination.

Do you want to improve the care of cancer patients by introducing new software medical devices to the global markets? Join RaySearch and our QA/RA team and contribute to make the best cancer treatments available for patients all over the world.

About the role

As one of our QA/RA Specialists, you will join the team of six dedicated coworkers. The role requires previous experience from regulatory submissions in USA or Canada.

The QA/RA team is central to the company’s business as it is responsible not only for product market clearances, but also for manufacturer certificates and the corporate Quality Management System.
This is a full-time position at RaySearch’s head office located in Stockholm. Presently, however, all team members are working from home. As QA/RA Specialist, you will report to the QA/RA Director and be involved in all areas of the department.

Your main tasks:

• File product submissions and obtain market clearances
• Identify market requirements and plan new submissions
• Assist our subsidiaries and distributors with regulatory questions
• Assist with both internal and external audits and inspections
• Lead or contribute to regulatory projects and vigilance activities
• Contribute to regulatory data quality in our customer and product database

The role is a great opportunity for you to contribute to the care of cancer patients by enabling new software innovations to be quickly and reliably introduced in markets worldwide. You will have contact with authorities, subsidiaries and distributors and work closely with an international team happy to share knowledge.

Your profile

To be successful in this role you work in a very structured and meticulous way. You have an interest in regulatory affairs and in explaining new software functionality to authorities. You adapt to changing conditions and have good communication skills. It is essential that you are well-organized but can be flexible when required. You recognize the importance of written processes and instructions and take initiatives to fill in any missing pieces. You can work independently and like to share your knowledge with colleagues.

Skills and experience:

• University degree or equivalent
• English at a high business level
• International business experience
• Working within a regulated area (medtech, law, government), 3-5 years’ experience
• Filing submissions to authorities

It is an advantage, but not required, if you speak Swedish, have experience from software industry and knowledge of ISO 13485, MDD/MDR and QSR.

Application

Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by e-mail, but if you have any questions about the position please contact David Hedfors, QA/RA Director, or Hanne Grinaker, QMS Manager.