Global Regulatory Intelligence Lead - Remote

CryoLife, Inc.; Kennesaw, Northern (GA, KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Artivion, Inc. is seeking a Senior Project Manager, Global Regulatory Intelligence to monitor and analyze worldwide regulatory changes, ensuring compliance and guiding strategic decisions across the organization.

The role partners with R&D, Quality, Clinical, Operations and other functions, developing regulatory strategies and advancing processes. Based in Kennesaw, GA, the position emphasizes collaboration, mentorship, and proactive risk management.

Qualifications

• Bachelor's degree in science, engineering or related field with 4+ years in regulatory/quality/compliance.
• Experience with FDA Class II/III or EU Class IIa/IIb/III devices.
• Experience interpreting new regulations and guidelines.
• Strong analytical and writing, organizational and time management skills.
• Ability to manage multiple projects in a fast-paced setting.
• Experience working with cross-functional teams.
• Proficiency with regulatory databases and MS Office.

Responsibilities

• Track global regulatory developments and interpret impact for the organization.
• Provide actionable insights to internal stakeholders and drive regulatory decisions.
• Lead regulatory projects and mentor junior staff.
• Maintain regulatory intelligence tools and databases.
• Collaborate with quality, clinical, legal and operations to ensure compliance.
• Support regulatory submissions and inspections.

Skills

Regulatory affairs

Regulatory analysis

Project management

Technical writing

Cross-functional collaboration

Communication skills

Attention to detail

Regulatory intelligence tools

Education

Bachelor's degree in science/engineering

Tools

Regulatory databases

Microsoft Office

Job description

Artivion, Inc. is seeking a Senior Project Manager, Global Regulatory Intelligence to monitor and analyze worldwide regulatory changes, ensuring compliance and guiding strategic decisions across the organization.

The role partners with R&D, Quality, Clinical, Operations and other functions, developing regulatory strategies and advancing processes. Based in Kennesaw, GA, the position emphasizes collaboration, mentorship, and proactive risk management.