Hands-on Regulatory Affairs Expert
Sunmedic AB · Vellinge, Sverige
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- Company
- Sunmedic AB
- Location
- Vellinge, Sverige
- Employment type
- Full-time
- Posted
- June 23, 2026
About this job
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…
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