Senior Regulatory Specialist

Globus Medical seeks a Senior Regulatory Specialist to prepare and submit FDA applications for Class II and Class III medical devices, including 510(k), IDE, and PMA submissions. The role requires expertise in medical device regulations, cross-functional collaboration, and attention to compliance throughout the product lifecycle.

Responsibilities

• Prepare and submit 510(k) applications to FDA for Class II and Class III products
• Develop and coordinate IDE and PMA submission packages with clinical and manufacturing teams
• Review and approve regulatory documentation including change orders, labeling, and Note-to-File records
• Maintain approved PMAs through supplements and annual report preparation and submission
• Determine appropriate regulatory pathways and train staff on regulatory processes

Requirements

• 5+ years medical device industry regulatory experience
• Bachelor's degree
• Working knowledge of FDA 21 CFR regulations and submission types
• Ability to evaluate regulatory impact of product and process changes
• Strong multi-tasking and project management skills
• Capability to work under pressure and meet strict deadlines