Principal Regulatory Affairs Specialist

SUMMARY:  Partner with Truvic's functional groups to efficiently deliver accurate, timely, and effective regulatory strategies, documents, deliverables and other projects in line with company objectives, policies and procedures.   Provide regulatory guidance with various ongoing cross-functional projects in order to remain in compliance with all FDA and other U.S. and international regulatory requirements. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.   Other duties may be assigned on an individual basis:

• Support business objectives by executing on the company’s regulatory strategy and priorities
  • Represent Regulatory discipline in Project Teams:   advise on bench, animal, and human clinical test plans, review and approve Design Control deliverables, provide information and advice to ensure regulatory risks, benefits, and timelines are understood
  • Develop US and OUS regulatory strategies, including predicate device identification, for products in development

• Prepare regulatory documents and filings such as Letter-To-File, Pre-Submission, 510(k), IDE, Technical Documentation File, Notified Body submissions and subsequent revisions/supplements and amendments by managing all associated deliverables and timelines
• Partner with Clinical in development of clinical strategy; review and approve trial protocols and reports and associated documentation
• Serve as the main contact to regulatory agency reviewers on submissions, coordinate with internal team members to respond to deficiency questions, and negotiate with regulatory agency reviewers for outcomes favorable to Truvic
• Review and approve Document Change Order requests, CAPAs, NCRs, Complaints, etc.
• Prepare various presentations to regulatory agency reviewers and/or inspectors as needed
• Ensure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocols
• Compile regulatory intelligence tracking for competitor products
• Develop appropriate procedures for the regulatory function
• Support the Operations teams and yield improvement projects
• Review and approve complaint data
• Provide regulatory information for management review
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
• Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements. 
• Actively promote and support the company’s Management Review process.  
• Inform responsible personnel of concerns involving product quality.
• Perform job functions in a safe and effective manner.
• Other duties as assigned

EDUCATION/EXPERIENCE:                                                                                                                                           

• Bachelor’s degree in a related field and 5 years’ experience in Regulatory Affairs in the medical device industry or 8 years’ increasingly responsible experience in related roles in healthcare-related industries 
• Experience in preparing US and/or OUS regulatory submissions, change order assessments
• An advanced degree is desirable, neurovascular product experience a plus
• Excellent written and oral communication skills; technical writing capabilities are a must
• Action-oriented style must be evident
• Ability to exercise independent judgment and decision making for routine programs
• RAC certification a plus
• Ability to prioritize multiple projects independently