Regulatory Affairs Manager

Jobtailor; Lake Forest (IL); On-site; USD 130,000 - 170,000; Full time

Job summary

Jobtailor is seeking a senior Regulatory Operations leader to manage the regulatory operations team and oversee data management for submissions, registrations, and product dossiers. The role requires strategic oversight and collaboration with cross-functional groups.

You will develop global regulatory strategies, guide preparation and submission activities, ensure inspections readiness and maintain strong relationships with regulators.

Qualifications

• Bachelor's degree required.
• Minimum eight years of experience in Medical Device or regulated industry, including three years in Regulatory Affairs.
• Minimum of two years’ management experience.
• Experience with Regulatory inspections and successful track record.

Responsibilities

• 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.

Skills

Regulatory Affairs

Regulatory Submissions

Team Leadership

Regulatory Data Management

Cross-Functional Collaboration

Regulatory Strategy

Education

Bachelor's degree

Job description

• 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