Regulatory Affairs Manager

Role: Provide strategic regulatory leadership for Invasive Cardiology medical devices, focusing on global premarket submissions, registrations, and post-market compliance. Responsibilities: develop and execute global regulatory strategies, support product launches, assess regulatory changes for existing products, review promotional materials, and lead inspection and inquiry support. Requirements: Bachelor's in Science or Engineering (or 12+ years relevant experience), 8+ years in Regulatory Affairs/Quality Assurance within the medical device or pharma industry. Preferred: advanced degree, RAPS certification, strong communication and leadership skills, demonstrated program management ability. HighValue: Invasive Cardiology devices, regulatory strategy, global premarket and post-market activities, device classification, cross-functional collaboration (engineering, product management), regulatory inspections, risk management. WorkSetup: not specified; no travel indicated.