Regulatory Affairs Manager (Hybrid)

ICU Medical • Lake Forest, CA

2d • Hybrid

About The Position

Manages the Regulatory Operations team responsible for various operational regulatory activities. Oversees the preparation, review, and submission of data and documentation to support regulatory applications and product registrations. Establishes and manages systems and processes to support the 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.
• Able to follow scientific arguments.
• Good interpersonal skills.
• Developing negotiating skills.
• Exceptional interpersonal skills; professional demeanor and attitude.
• High level of attention to detail.
• Understands the key requirements in the submission development process to facilitate regulatory submission publishing.
• Demonstrate the proven capability to define, plan, and execute projects involving a diverse cross-functional team within the established boundaries of quality, time and budget.
• Excellent verbal and written communication skills.
• Strong understanding of business needs.
• Must have strong experience with word-processing, spreadsheet, presentation and other document publishing software.

Responsibilities

• Provides regulatory advice and support to assigned software products/teams.
• Identifies and communicates registration needs and strategies.
• Maintains awareness of applicable regulations.
• Plans and organizes software registration packages.
• Timely and accurate preparation of registration packages in line with local regulatory requirements and guidelines.
• With oversight, serves as a liaison with regulatory agencies pertaining to assigned products/teams.
• Assists in the preparation of agency meeting packages and strategies for agency meetings.
• Evaluates product and labeling changes for regulatory impact with guidance.
• Accurately describes these changes for ease of regulatory agency review.
• Represents Global Regulatory Affairs at project meetings.
• Manages Regulatory Operation processes and drives continuous improvement by facilitating, leading, and collaborating with cross-functional teams.
• Manages publishing activities for US, EU and Canada device submissions to ensure timely registrations and product launches.
• Ensures U.S. CFG requests and facility registration are processed timely.
• Provides support for drug submissions as needed.
• Establishes and maintains a system for management of regulatory data.
• Identifies, develops, validates, and maintains Regulatory Operations systems and software with coordination with IT when applicable.
• Represents Regulatory Affairs for areas assigned for regulatory agency interactions (either written or oral) including internal and external audits, and inspections.
• Ensures that Regulatory Operations resources are optimized and working in an efficient manner.
• Effectively manages others in the accomplishment of tasks and collaborates with others to ensure success.
• Performs other duties as assigned or required.

Benefits

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Paid Time Off
• Company Holidays
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Manager