SUMMARY: Manage day to day activities for Regulatory Affairs function. Partner with internal departments and external consultants to efficiently deliver accurate, timely, and effective regulatory documents, deliverables and other projects in line with company 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:

• Partner with Senior Management to define and execute on the company’s regulatory strategy and priorities

• Key contact for FDA and Notified Body submissions and onsite audit management
• Prepare regulatory filings such as 510(k), IDE, Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments by managing all associated deliverables and timelines

• Represent Regulatory discipline in Project Teams to ensure timelines and resource allocations are factored into deliverables
• Develop global regulatory strategies for various projects

• Prepare various presentations to regulatory agency reviewers and/or inspectors as needed
• Review and approve Documents Change Order requests, CAPA’s, NCMR’s, etc.
• Ensure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocols
• Manage coordination of international product registrations and licensing documentation
• Partner with Clinical to provide input and prepare critical data for physicians and proposals
• Act as regulatory representative on project teams to ensure timeliness and resource allocations are factored into deliverables
• Develop and manage departmental budgets
• 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 10 years’ experience in healthcare-related industries, including 5 or more years’ experience in the medical device industry
• Expertise with MDRs, IDEs and 510(k) filings
• An advanced degree is desirable. Medical device product experience a plus.
• Excellent written and oral communication skills; technical writing capabilities are a must
• A proven decision maker, hands-on and action-oriented style must be evident
• Prior management training and experience is desired
• RAC certification a plus
• Proven ability to manage a team of regulatory professionals and prioritize multiple projects independently