EDUCATION

• Bachelor’s degree in science, engineering or relevant technical discipline

EXPERIENCE

• 10+ years of regulatory experience in a tissue, biologics, medical device, or pharmaceutical company with knowledge of FDA, ISO, AATB and MDR labeling, and quality system requirements
• 7+ years of leadership experience

SKILLS

• Excellent verbal and written communication
• Microsoft Office Suite
• Enterprise Resource Planning (ERP) software
• Budget Management
• Project Management
• Process Improvement Methodologies
• Strategic Planning

• Provides strategic leadership for the regulatory function, setting the vision and goals for the department and leading a high-performance team of professionals
• Executes and manages technical and scientific regulatory activities independently as a decision-maker on regulatory issues and assures that deadlines are met
• Directs staff, including consultants, to assure timely and accurate preparation of domestic and international regulatory submissions
• Authors or reviews key portions of technical files/dossiers, FDA premarket submissions such as 510(k) and IDE, Canadian devices licenses, and other international product registrations
• Negotiates and interacts with regulatory authorities during the development and review process to ensure successful submission approval
• Serves as primary contact for regulatory agencies in matters related to product submissions and registrations
• Identifies emerging issues and anticipates regulatory obstacles throughout the product lifecycle and develops solutions in collaboration with members of regulatory and cross functional teams
• Oversees regulatory maintenance of product marketing registrations, approvals, and clearances
• Manages the development process (e.g., design, development, approval, implementation, control, revision, and translation) of product labeling (e.g., package labels, ancillary labels, package insert, and surgical technique) to assure accuracy, consistency, and compliance with applicable regulatory requirements, as well as company and customer requirements
• Negotiates labeling-related requests from internal stakeholders and business partners based on manufacturing capabilities and regulatory requirements
• Reviews and approves advertising and promotional items to ensure regulatory compliance and ensures external communications meet regulations
• Participates in audits and inspections by regulatory authorities and certification or accreditation bodies
• Communicates with customers as needed on regulatory related matters with a high level of customer service
• Maintains knowledge of the global competitive landscape, regulatory environment, regulations, guidance, and provides updates to peers and project teams
• Contributes to the development and maintenance of Regulatory Affairs working practices and procedures
• Other duties as assigned