Regulatory Affairs Support Specialist

Do you have an interest in quality management and learning more about regulatory vigilance? Join RaySearch and our QA/RA team and contribute to make the best cancer treatments available for patients all over the world.

About the position

Joining RaySearch as our new Regulatory Affairs Support Specialist, you will be a part of our QA/RA team of six dedicated specialists and administrators. The position 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 communication with regulatory authorities and obtaining 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 new Hagastaden life-science hub in Stockholm. As Regulatory Affairs Support Specialist, you will focus on regulatory vigilance and reporting to authorities. You will report to the QA/RA Director and be involved in all areas of the department.

Your main tasks:

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

This position is a great opportunity for you who wants to work with regulatory data management in medtech. You will be in 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 position 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 Alinne Andersson. HR.