Regulatory Affairs Manager

Manages the Regulatory Operations team responsible for various operational regulatory activities. Oversee the preparation, review and submission of data and documentation to support regulatory applications, product registrations. Establishes and manages systems and processes to support publishing of regulatory submission packages, product and facility registrations and regulatory data management. Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products. May serve as a lead regulatory representative to an assigned product or project team. Interacts with various regulatory agencies and internal ICU Medical cross functional organizations. Requirements Must be at least 18 years of age. Bachelor’s degree from an accredited college or university is required. Minimum eight years of experience in Medical Device, or regulated industry, specifically three years in Regulatory Affairs Minimum of two years’ management experience Experience with Regulatory inspections and successful track record Core Competencies Demonstrates expertise in Regulatory Affairs within the Medical Device industry, with a strong focus on managing regulatory operations, developing global regulatory strategies, and ensuring compliance with regulatory agencies. Proven leadership in overseeing regulatory submissions and managing cross-functional teams. Highest-signal resume keywords Regulatory Affairs Management Medical Device Industry Experience Regulatory Submissions Preparation Regulatory Inspections Experience Team Leadership ATS Optimization Keywords Hard Skills Regulatory Data Management Regulatory Strategy Development Product Registration Documentation Review Regulatory Compliance Soft Skills Cross-Functional Collaboration Interpersonal Communication Leadership Industry Keywords Regulated Industry Regulatory Operations Regulatory Agencies Product Registrations Regulatory Submission Packages #J-18808-Ljbffr