Regulatory Affairs Professional

Become part of our team as a Regulatory Affairs Professional, where you will prepare and maintain regulatory submissions and documentation, and provide subject matter expertise to cross-functional teams. Ideal for candidates with experience in IVDs or medical devices and strong organisational skills.

Skills

• regulatory submissions
• fda pma annual reports
• ivdr class d recertifications
• 510(k) submissions
• quality management system
• technical file preparation
• regulatory compliance
• regulatory strategy
• design dossier review
• dea audits
• gmp environment
• medical device market clearance
• ivd products
• cross-functional collaboration
• training delivery
• audit preparation
• azure devops
• microsoft office
• sharepoint
• adobe acrobat
• outlook
• presentation skills
• intercultural sensitivity