Care for data quality and want to work with regulatory reporting and suppor

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 380 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 have an interest in data management and learning more about Quality and Regulatory Affairs? 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

Joining RaySearch as our new RA Support Specialist, you will be a part of our QA/RA team of four dedicated specialists and an administrator. The role does not require previous experience from the QA/RA field, but we would like to see that you have experience from working in a regulated area.

The 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 the heart of Stockholm. Presently, however, all team members are working from home. As RA Support Specialist, you will report to the QA/RA Director and be involved in all areas of the department.

Your main tasks:

• Ensure regulatory data quality in our customer and product database
• Send and follow-up vigilance reports to authorities
• Assist the QA/RA team with data management
• Review and update records and documents
• Monitor vigilance reporting status

The role is a great opportunity for you who want to work with regulatory data handling in medtech. You will have contact with international authorities and work closely with dedicated QA/RA specialists who are happy to share their knowledge.

Your profile

To be successful in this role you have the ability to work in a very structured and meticulous way. You have an interest in data quality management and organizing records and documents, maybe from working within a regulated area such as medtech/life science, finance, public sector or government. You enjoy assisting others and solving problems, have good communication skills, listen actively to what others have to say and adapt your communication to the situation. We think that you are proactive and enjoy working on several tasks in parallel without losing attention to detail. It is essential that you are well-organized but can be flexible when required. You easily follow verbal and written instructions and take initiatives to clarify any missing pieces. In addition, you have strong team working skills and openly share your knowledge with colleagues.

Skills and experience:

• University degree or equivalent
• 2+ years’ experience of data structuring or document management work tasks
• Database user skills
• English at a high business level

It is an advantage, but not required, if you speak Swedish, have experience from submitting reports to authorities or similar, international business communication and working within a regulated area, especially with ISO 13485, QSR or MDR.

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.