Principal Regulatory Affairs Specialist - Software Devices

POSITION SUMMARY:

The Principal Regulatory Affairs Specialist will report to the Director of Regulatory Affairs and will work with Product Development, Quality, Operations, and Marketing to support the product development process and meeting all applicable regulatory requirements. The Principal Regulatory Affairs Specialist will work with Marketing, Sales, Legal and Regulatory partners on advertising and promotional materials as well as product labeling while meeting all applicable regulatory requirements. The Principal Regulatory Affairs Specialist will support daily regulatory operations and regulatory data management as well as monitor and assess applicable regulatory landscape changes.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Serves as the Regulatory representative providing regulatory guidance to product development and sustaining project teams.
• Authors US FDA premarket submission (e.g., 510(k), Q-submissions) and international submissions for medical devices, including software devices (SaMD, SiMD), with collaboration from key staff in Product Development, Operations, Marketing, and Quality for timely submissions.
• Serves as primary contact for regulatory agencies on assigned submissions and negotiates submission data requirements and deliverables with regulatory authorities and product development teams for timely clearance.
• Authors regulatory assessments for proposed changes to products or processes.
• Collaborates with Marketing, Sales, Legal and Regulatory partners for timely review of advertising and promotional materials as well as product labeling.
• Monitors regulatory landscape changes and authors impact assessments to key proposed or issued regulatory guidance, directives, and legislation. Interprets changes for implementation into TMC processes.
• Maintains US FDA and international registrations and device listings.
• Supports the Unique Device Identifier (UDI) program and US FDA Global Unique Device Identification Database (GUDID) submissions.
• Maintains regulatory data, files, and daily regulatory operations.
• Participates in audits by regulatory authorities, certification bodies, or internal auditors.
• Mentors junior Regulatory staff and guides for cross-functional understanding of applicable regulatory requirements and processes.
• Develops Regulatory trainings for departmental and cross-functional understanding of regulatory requirements and procedures.
• Develops Regulatory processes and procedures for departmental efficiencies.