Hands-on Regulatory Affairs Expert

Sunmedic is a medical device company focused on developing safe and effective products. We are looking for a hands-on Regulatory Affairs Expert who can take ownership of technical documentation, ensure regulatory compliance, and work closely with quality and development teams. What you will do - Prepare, maintain, and update technical files and regulatory documentation in line with EU MDR and other applicable regulations. - Handle regulatory submissions (EU MDR) and manage lifecycle activities including updates and variations. - Support and maintain the quality management system (ISO 13485), including quality control documentation and records. - Review and assess design changes, labeling updates, and material changes for regulatory impact. - Collaborate with Quality Assurance and R&D teams to ensure technical documentation is complete, accurate, and audit-ready. - Prepare for and support audits and inspections by notified bodies and competent authorities. - Contribute to post-market surveillance activities and the preparation of related reports (e.g., PMCF, PSUR). - Monitor regulatory updates and implement necessary changes in technical files and quality documentation. Who you are - A practical and detail-oriented regulatory professional who enjoys working directly with technical files and documentation. - Comfortable working in a fast-paced environment where you need to deliver concrete regulatory outputs. - Proactive in identifying compliance gaps and implementing practical solutions. - Clear communicator who can work effectively with Quality, R&D, and external auditors. What you have - Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field. - At least 2 years of ,hands-on regulatory affairs experience, in the medical device industry. - Solid experience preparing and maintaining, technical files, and working within a quality management system (ISO 13485). - Good knowledge of EU MDR requirements and regulatory submissions. - Strong organizational skills and attention to detail when managing documentation and multiple tasks. - Proficiency in English (written and spoken). Nice to have: - Experience with post-market surveillance and clinical evaluation reports. - Familiarity with US FDA 510(k) or UK MDR submissions. - Previous involvement in audits or inspections. What we offer - Competitive salary and benefits. - Flexible working arrangements. - The opportunity to work closely with product development and quality teams on real regulatory deliverables. How to apply Please send your CV and a short cover letter describing your experience with technical files, quality systems, and regulatory submissions, to abbas.karladani@sunmedic.se. Mention any specific documentation or projects you have worked on.