Senior Regulatory Affairs Specialist

We are currently hiring a Senior Regulatory Affairs Specialist to prepare and maintain regulatory submissions, guide new product development, and ensure compliance with US/EU medical device regulations. Ideal candidates will have significant experience in IVDs or medical devices and strong expertise in regulatory processes.

Skills

• regulatory affairs
• fda 510(k) submissions
• ivdr class c recertifications
• technical files
• quality management system
• gmp environment
• outlook
• sharepoint
• excel
• azure devops
• intercultural sensitivity
• presentation skills
• team orientation
• attention to detail
• multi-tasking
• regulatory compliance