Global Regulatory Intelligence, Senior Project Manager

Company Overview:

Headquartered in suburban Atlanta, Georgia, 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. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

The Sr. Project Manager, Global Regulatory Intelligence will monitor, gather, and analyze global regulatory changes and trends to provide insights that ensure compliance and support strategic decision-making for the global regulatory organization. The role is a key partner in ensuring regulatory compliance across the organization with existing and changing regulation.

Key duties include tracking regulations and standards, triaging the changes for assessment and tasks, assessing impact on business operations, advising internal teams on compliance, and helping to develop regulatory strategies. The role will also support process improvements, internal reporting and advance system capabilities. In collaboration with senior RA Management, the role will work directly with industry organizations, regulatory bodies and external services to monitor regulations/standards and support compliance for Artivion product and processes. The individual has department and cross-functional influence and is generally recognized as an expert resource within the department. This role will collaborate with global Artivion stakeholders (e.g. R&D, Quality, Clinical, Operations) as subject matter expert and will mentor junior staff, as appropriate.

Responsibilities:

• The role will track, monitor, analyze, and interpret global regulatory developments (regulations, guidelines, standards and legislation) to ensure compliance and strategic decision-making within the organization.
• Proactively identify, mitigate, and manage potential regulatory or compliance risks by staying ahead of upcoming changes and initiatives. Communicate new and upcoming changes. Facilitate and assist with interpretation to guide product and business compliance with regulatory requirements.
• The role will assess impact to business operations and provide insights to functions and teams. Provide actionable insights to internal stakeholders. Drive internal review and implementation with Subject Matter Experts. Ensure projects and tasks meet business objectives and expectations.
• Manage and utilize regulatory intelligence tools, databases, and other information resources to maintain a knowledge base and improve processes.
• Maintain expert proficiency in worldwide regulatory requirements; establish and maintain advanced relationships with agency personnel and industry organizations. Collaborate with functional partners to implement regulatory changes to regulatory/compliance documentation and procedures. Drive issues to resolution.
• Act as a Regulatory Subject Matter Expert (SME) on key topics and provide strategic guidance to regulatory affairs, functions, and cross-functional teams. Collaborate with quality, clinical, legal, and operations to align regulatory intelligence strategies.
• Influences management on technical or business solutions related to regulatory intelligence. Develop network of internal partners and be a subject matter expert to ensure projects meet regulatory requirements.
• Establish and maintain positive relationships with stakeholders and team members. Leverage experience and technical knowledge to advance corporate strategies.
• Examine and recommend opportunities within industry to advance organizational objectives.
• This position requires strong collaboration, communication, and analytical skills to support product development, market access, and post-market activities in alignment with global regulatory requirements.
• The role involves using regulatory databases and specialized software. Train others in the use of regulatory systems and tools. Advise on process improvements and lead to completion, where assigned. Drive to solutions.
• Communicate complex regulatory information clearly and concisely to various internal teams, such as product development, research, operations