Senior Regulatory Affairs Specialist at A3P BiomedicalA3P Biomedical is a Swedish diagnostics company specializing in advanced prostate cancer diagnostics. Our main product, Stockholm3, is a blood test for early detection of aggressive prostate cancer — with the potential to radically improve diagnostics and reduce mortality in one of the world's most common cancers. We are currently active in Switzerland, Germany, the UK, the US, Austria, Poland, Turkey, Sweden, Norway, and Finland.To strengthen our Quality & Regulatory Affairs team, we are looking for a Senior Regulatory Affairs Specialist to join us. You'll be part of a small, dedicated team with direct responsibility for maintaining regulatory compliance for Stockholm3 throughout its product lifecycle, while supporting the company's continued growth and international expansion. This is a role for someone who enjoys combining strategic and operational work, takes ownership naturally, and wants their day-to-day work to make a real difference in patients' lives.Your responsibilitiesDevelop and maintain regulatory strategies for Stockholm3 throughout its product lifecyclePrepare, review, and maintain Technical Documentation in accordance with IVDR and applicable standardsCoordinate regulatory submissions and communication with Notified Bodies and Competent AuthoritiesAssess the regulatory impact of product changes and support change management activitiesSupport Performance Evaluation documentation and regulatory assessments in accordance with IVDRLead and maintain Post-Market Surveillance (PMS) activities, including PMS Plans and PMS ReportsMonitor changes in regulatory requirements and ensure continued complianceAct as the company's regulatory subject matter expert, providing guidance and support across the organizatio…