Senior Regulatory Affairs Specialist at A3P Biomedical

Senior Regulatory Affairs Specialist at A3P Biomedical A3P 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 responsibilities Develop and maintain regulatory strategies for Stockholm3 throughout its product lifecycle Prepare, review, and maintain Technical Documentation in accordance with IVDR and applicable standards Coordinate regulatory submissions and communication with Notified Bodies and Competent Authorities Assess the regulatory impact of product changes and support change management activities Support Performance Evaluation documentation and regulatory assessments in accordance with IVDR Lead and maintain Post-Market Surveillance (PMS) activities, including PMS Plans and PMS Reports Monitor changes in regulatory requirements and ensure continued compliance Act as the company's regulatory subject matter expert, providing guidance and support across the organization Participate in internal and external audits and contribute to the continuous improvement of the Quality Management System Working hours Full-time. Required qualifications MSc (or equivalent) in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or another relevant scientific discipline At least five years of experience within Regulatory Affairs in the medical device or in vitro diagnostics industry Solid knowledge of IVDR (EU 2017/746) and ISO 13485 Experience preparing and maintaining Technical Documentation Experience working with Notified Bodies and Competent Authorities Experience with Post-Market Surveillance and regulatory lifecycle management Experience with Software as a Medical Device (SaMD) regulatory requirements Excellent medical and scientific writing skills Strong command of English, written and spoken Meriting qualifications Experience with FDA regulations and international regulatory submissions What we're looking for in you You're proactive, structured, and solution-oriented, with strong analytical skills and an eye for detail. You work well independently but collaborate easily across the organization, communicate clearly, and build strong professional relationships. You take pride in seeing things through — from planning to implementation — and you thrive in a dynamic environment where priorities can shift. At A3P Biomedical, you'll join an ambitious, entrepreneurial team with a global mission: improving men's health and transforming prostate cancer diagnostics. Your work will have direct clinical impact. If you want to be part of a growing company that values collaboration, curiosity, and quality, we'd love to hear from you. Learn more about us at A3P Biomedical. Submit your application in English no later than 10 September. Selection and interviews are held continuously, so don't wait to apply — the position may be filled before the deadline. This position is based in Stockholm or Uppsala, Sweden.