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 1,600 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, .
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, and quality.
- Lead complex technical projects with considerable initiative and independence, strategic and critical thinking, and effective decision-making skills, with the ability to prioritize and balance multiple competing priorities and escalate issues when critical risks arise. Advanced project management skills applied to all assignments.
- May support regulatory submissions. Track and report the status of regulatory actions and submissions to internal stakeholders.
- Participate in inspections, audits, and post-audit corrective actions.
- Ensure understanding of all quality policy/system items, as applicable. Maintain and update regulatory processes and SOPs. Follow all work/quality procedures to ensure quality system compliance. Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.).
Qualifications:
Required:
- Bachelor's degree in science, engineering or related field, with a minimum of 4 years of regulatory, quality, and/or compliance experience in medical device or biologics.
- Experience with FDA Class II or III devices or experience with EU Class IIa/IIb or III devices.
- Experience with interpretation and application of new regulations, legislation, standards or guidelines.
- 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.
- Strong ability to sift through complex information, discern high-quality data, and translate it into meaningful intelligence.
- Excellent verbal and written communication skills are essential for conveying complex regulatory topics to diverse internal audiences.
- Proficiency with regulatory intelligence databases and monitoring tools, and general office software.
- Strong attention to detail for accurately tracking and interpreting regulatory information.
- Experience working with cross-functional teams.
- Ability to comprehend principles of engineering, physiology, and medical device use.
- Ability to effectively manage and prioritize numerous projects and responsibilities.
- Strong analytical, technical writing, verbal/written communication, organizational, and time management skills.
- Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.
- Project management experience.
- Ability to effectively manage and prioritize numerous projects in a fast-paced environment.
- Expertise in Microsoft Office Suite
Preferred:
- Experience with US FDA, Notified Body interaction, and Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices and/or human tissue preferred.
- Ability to apply experience to ensure regulatory affairs compliance and cross functional interaction