Principal Regulatory Affairs Specialist - Remote

Overview

The Principal Regulatory Affairs Specialist plays a vital role in the SeaSpine Regulatory Affairs department, providing experienced support and guidance on regulatory strategy for product development in the medical device industry.

In Short

• Provide regulatory guidance to various teams including quality systems and product development.
• Independently prepare and submit regulatory filings such as 510(k)s.
• Define strategy for device labeling and promotional materials.
• Support quality assurance during FDA inspections and audits.
• Maintain compliance of manufacturing processes with regulatory standards.
• Educate and train regulatory team members.
• Coordinate with other team members for international registrations.
• Manage multiple competing projects with minimal oversight.
• Drive projects to stay updated on new regulations.
• Participate in project planning and design control meetings.

Requirements

• Bachelor’s Degree required.
• A minimum of 4 years in the medical device industry.
• 2-4 years of regulatory affairs experience.
• Proven ability to submit documents to FDA and CE marking.
• Effective written and verbal communication skills.
• Ability to interface with diverse disciplines.
• Experience with FDA 510(k) submissions preferred.
• Experience with EU MDR is highly desired.
• Ability to train others and prepare presentations.
• Strong project management skills.

Benefits

• Work with a global team in a leading medical device company.
• Opportunity to impact patient care and quality of life.
• Collaborative work environment.
• Career development and training opportunities.
• Innovative and supportive company culture.