Principal Specialist, Regulatory Affairs

About This Role

This role is responsible for managing product activities related to regulatory submissions and registration for Arthrex's medical devices. The Principal Specialist will develop regulatory strategies, execute regulatory plans, and ensure compliance for new and existing products.

Responsibilities

• Develop U.S., EU and Canada regulatory strategy and implementation plans for new products and review proposed changes for regulatory impact
• Evaluate the risk of proposed regulatory strategies and offer solutions
• Advise Product Development Teams on regulatory requirements for FDA, EU MDR & Health Canada submissions
• Prepare, write, and submit FDA, Notified Body and Health Canada submissions for new products and changes
• Partner with International Regulatory Affairs to provide regulatory support for new products and changes
• Review and approve design control documentation, engineering change requests, and customs requests for global regulatory compliance
• Provide feedback and support to Product Development Teams to resolve regulatory issues and questions from agencies
• Rigorously review regulatory documentation for completeness, clarity, consistency, and conformance to regulations
• Provide support to currently-marketed products, including reviewing labeling and promotional material, and preparing submissions for changes
• Interact with FDA, Notified Bodies and/or Health Canada on products at reviewer level

Requirements

• 10+ years of relevant experience, preferably in regulatory affairs within the life science industry
• Bachelor's degree
• Experience authoring and submitting medical device registrations/licenses/submissions
• Experience reviewing product labeling and advertising/promotional material for medical devices

Qualifications

• Bachelor’s degree required, engineering or science discipline preferred. Advanced degree preferred.
• 10+ years relevant experience required preferably in a regulatory affairs role in the life science industry.

Nice to Have

• Advanced degree
• Orthopedic medical device experience

Skills

* Required skills

Benefits

Certifications