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…

Hands-on Regulatory Affairs Expert