Project Manager, Regulatory Affairs
ArtivionGeorgia, United States
Posted September 29, 2025
Full Time
About the Company
Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases.
Job Description
Project Manager, Regulatory Affairs provides technical leadership and implements regulatory strategies that deliver organizational objectives. The role involves obtaining and maintaining regulatory approvals and compliance for medical devices and/or tissue products.
Requirements
- Bachelor's degree in science, engineering or related field
- 5-7 years of regulatory, quality, and/or compliance experience in medical device or biologics industries
- Experience with FDA Class II or III devices or EU Class IIa/IIb or III devices
- Strong analytical, technical writing, communication, organizational, project management, time management, and interpersonal relationship skills
- Awareness of global regulatory affairs, product development and total product lifecycle processes
- Ability to comprehend principles of engineering, physiology, and medical device use
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance