Senior Regulatory Affairs Specialist

About the role

Seeking an experienced Regulatory Affairs Specialist to lead regulatory strategy for our innovative medical device portfolio.

What you'll do

• •Develop and execute regulatory strategies for US and global markets
• •Prepare and submit FDA 510(k) and PMA applications
• •Interact with FDA and other regulatory agencies
• •Provide regulatory guidance to cross-functional teams
• •Maintain regulatory intelligence and track regulatory changes

What we're looking for

• •5+ years of regulatory affairs experience in medical devices
• •Proven track record of successful FDA submissions
• •Deep understanding of FDA regulations and guidance
• •Strong project management skills

Qualifications

Bachelor's degree in Life Sciences or related field required. Master's degree or RAC certification preferred.

Skills