Hands-on Regulatory Affairs Expert
Sunmedic AB · Vellinge, Sverige
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- Firma
- Sunmedic AB
- Plaz
- Vellinge, Sverige
- Aart vum Kontrakt
- Vollzäit
- Publizéiert den
- 23. Juni 2026
Iwwer dës Plaz
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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