Senior Global Regulatory Intelligence Lead

Artivion, Inc.; Kennesaw (GA); On-site; USD 110,000 - 140,000; Full time

Job summary

Artivion, Inc. in Georgia is seeking a Sr. Project Manager, Global Regulatory Intelligence to monitor global regulatory changes and provide insights to ensure compliance across the organization.

You will collaborate with R&D, Quality, Clinical, Operations and external bodies, manage regulatory intelligence tools, and support regulatory submissions and process improvements. This role requires strong collaboration, exceptional communication, project management skills, and the ability to lead

Qualifications

• Bachelor's degree in science, engineering or related field with regulatory/compliance experience.
• Experience with FDA Class II/III devices or EU Class IIa/IIb/III devices.
• Strong analytical, writing, communication, and organizational skills.
• Ability to lead regulatory projects and collaborate across functions.

Responsibilities

• Track, monitor, analyze, and interpret global regulatory developments to ensure compliance.
• Identify and mitigate regulatory or compliance risks and communicate changes.
• Provide actionable insights to internal stakeholders and drive implementation with SMEs.
• Manage regulatory intelligence tools, databases, and knowledge bases.

Skills

Regulatory affairs

Quality assurance

Project management

Technical writing

Cross-functional collaboration

Regulatory intelligence tools

Education

Bachelor's degree in science/engineering

Tools

Regulatory databases

Microsoft Office

Job description

Artivion, Inc. in Georgia is seeking a Sr. Project Manager, Global Regulatory Intelligence to monitor global regulatory changes and provide insights to ensure compliance across the organization.

You will collaborate with R&D, Quality, Clinical, Operations and external bodies, manage regulatory intelligence tools, and support regulatory submissions and process improvements. This role requires strong collaboration, exceptional communication, project management skills, and the ability to lead