Regulatory Affairs Sustaining Specialist

About the role

Regulatory Affairs Sustaining Specialist at Enovis. Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself.

What you'll do

• We seek top talent, foster continuous innovation, and are driven by the desire to improve ourselves day by day
• This includes overseeing the change management process for products and related processes
• Preparation, updating, and management of technical documentation for the registration and maintenance of medical devices in accordance with Regulation (EU) 2017/745 (MDR)
• Cross-functional collaboration with product development, quality, clinical and manufacturing teams to gather necessary information for compiling technical files
• Regulatory management of product/process changes (e.g., reportability assessment, notification of changes to notified bodies/competent authorities)

What you need

• 1–2 yrs of experience
• Regulatory affairs
• Biology
• Chemistry
• Documentation
• Any graduate