- 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