Global Regulatory Intelligence Lead - Medical Devices

Artivion; Kennesaw (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

Artivion, Inc. in the Atlanta area seeks a Sr. Project Manager, Global Regulatory Intelligence to monitor and analyze global regulatory changes and provide strategic insights enabling compliance across the organization.

You will collaborate with R&D, Quality, Clinical, Operations and external bodies to shape regulatory strategies, manage regulatory intelligence tools, mentor staff, and drive complex projects from initiation to completion.

Qualifications

• Bachelor's degree in science, engineering or related field with 4+ years regulatory/quality/compliance experience in medical devices.
• Experience with FDA Class II or III devices or EU Class IIa/IIb or III devices.
• Experience interpreting and applying new regulations, legislation, standards or guidelines.
• Strong writing, communication, organizational and interpersonal skills.
• Global regulatory affairs awareness and lifecycle knowledge.
• Ability to translate complex regulatory data into actionable intelligence.
• Excellent verbal and written communication for diverse audiences.
• Proficiency with regulatory databases and monitoring tools; MS Office familiarity.
• Attention to detail and ability to manage multiple projects.
• Experience with cross-functional teams.
• Engineering/physiology understanding and regulatory application.
• Project management capability and ability to prioritize.
• Expertise in Microsoft Office Suite.

Responsibilities

• Track, monitor, analyze, and interpret global regulatory developments to ensure compliance and strategic decision-making.
• Identify regulatory risks, communicate changes, and guide product and business compliance.
• Provide actionable insights to internal stakeholders and coordinate with SMEs.
• Manage regulatory intelligence tools, databases, and information resources.
• Maintain expert proficiency in worldwide regulatory requirements and engage with agencies/industry groups.
• Act as Regulatory SME to guide cross-functional teams and mentor junior staff.
• Lead regulatory projects with initiative, strategic thinking, and prioritization.
• Support regulatory submissions and track status of actions.
• Participate in inspections, audits, and post-audit actions.
• Maintain and update regulatory processes and SOPs; support quality programs.

Skills

Regulatory intelligence

Regulatory compliance

Project management

Communication

Analytical thinking

Cross-functional collaboration

Technical writing

Regulatory databases

Education

Bachelor's degree in science/engineering

Tools

Microsoft Office Suite

Regulatory intelligence databases

Job description

Artivion, Inc. in the Atlanta area seeks a Sr. Project Manager, Global Regulatory Intelligence to monitor and analyze global regulatory changes and provide strategic insights enabling compliance across the organization.

You will collaborate with R&D, Quality, Clinical, Operations and external bodies to shape regulatory strategies, manage regulatory intelligence tools, mentor staff, and drive complex projects from initiation to completion.