Descripción
RaySearch develops innovative software solutions to improve cancer care. Over 1200 clinics in more than 54 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe, Asia and Australia & New Zealand. Today we are more than 485 employees with a common vision of 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. As a Regulatory Affairs Support Specialist, you will join our Quality Assurance and Regulatory Affairs team of dedicated specialists working to ensure compliance with global medical device regulations and to bring innovative cancer treatment solutions to patients worldwide. About the role In this role, you will take ownership of RaySearch's regulatory vigilance activities and work closely with colleagues across Quality Assurance, Regulatory Affairs, Service, Development. You will be responsible for assessing, reporting and following up on vigilance cases, while also supporting regulatory submissions and registrations in global markets. This is an excellent opportunity for someone with a few years of experience in medical device regulatory affairs who wants to deepen their expertise in vigilance and continue developing within global regulatory affairs. The position is based at RaySearch's headquarters in Stockholm and reports to the Group Manager Regulatory. Your main responsibilities: Own and coordinate regulatory vigilance activities Assess complaints and incidents for reportability under applicable regulations Prepare, submit and follow up vigilance reports with competent authorities and notified bodies Support post-market surveillance