The Director, Regulatory Affairs, Advertising & Promotion is responsible for strategic direction and regulatory compliance on all product claims by providing sound regulatory advice that minimizes the risk of regulatory and legal action, competitively positions marketed products, and is consistent with applicable global regulations and West corporate policies. Essential Duties and Responsibilities: • Provide strategic regulatory expertise and operational direction to management, internal, and external customers to ensure conformance with corporate requirements, government regulations, guidelines and industry standards as it relates to promotional compliance and product claims. Preferred Knowledge, Skills and Abilities: • Exceptional ability to independently problem solve, negotiate, influence, and collaborate cross-functionally while maintaining a risk-based mindset • Expertise in US and OUS regulations for medical device advertising and labeling • Experience in medical device regulatory affairs, direct interactions with regulatory agencies, and management of regulatory support systems. Sedentary work involves sitting most of the time. Ability to write and record data and information as required by procedures.
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