Artivion, Inc.

Clinical Research

• Supports regulatory submissions to competent authorities.
• May act as a site manager, and may provide site training.
• Interacts with sites in accordance with local law, standards, and regulations.
• Participates in vendor selection process.
• Works with vendor on contracts.
• Manages invoices.
• Collaborates on core clinical documents.
• Represents the core clinical documents and study processes to participating sites in the context of Site Regulatory Binders.
• Executes/supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs)/Ethics Committee (EC) for approval.
• Ensures maintenance of IRB/EC approval throughout the duration of the study.
• Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary.
• Assists with developing Health Care Provider (HCP) presentations.
• May engage with cross functional teams.
• Facilitates queries for all missing or inaccurate data.
• Ensures that data changes are properly implemented and captured in the database or data system.
• Assists in the evaluation and analysis of clinical trial data.
• Disseminates publications to sites as necessary.
• Review clinical reports and conduct quality and consistency checks for regulatory submission and/or scientific publication.
• Learn the function and clinical applications of a surgical implant which treats complex heart disease conditions, understand the indication, safety, and performance objectives and parameters and ensure consistency across multiple clinical documents.
• Contribute to EU Medical Device Regulation processes and documentation generation and support submissions to Notified Bodies.
• Support ongoing Post-Market Surveillance and Quality Assurance activities
• Ability to travel domestically and internationally up to 30% of the time.

Clinical Research Project Manager

Compliance

• Support manufacturing site needs to meet local objectives and maintain regulatory compliance.
• Provides support for product regulatory compliance maintenance activities for approved products.
• Responsible to maintain compliance for marketed products, including review of labeling, promotional material, product change assessments and documentation for changes.
• Support regulatory commercialization activities, including listing and authorization within the enterprise resource system and/or other related databases.
• Support regulatory compliance activities, including facility site registrations, audits, etc., as needed.
• Work with cross-functional teams and subject matter experts to maintain regulatory compliance.
• Team with international regulatory colleagues to provide regulatory support for changes to existing products.
• Align with RA leadership on the reviews needed for significant product submissions with project stakeholders.
• Author accurate and complete submission content with support from management.
• Provide feedback and on-going support to product teams for regulatory questions.
• Generates and executes regulatory or compliance activities under management direction.
• Maintain awareness/have a beginner to intermediate understanding of worldwide regulatory requirements; maintain awareness of agency relationship and ensure RA leadership is prepared with sufficient information to support relationships with external agency personnel.
• Provide basic project management techniques for task management and deliver to defined plans.

Regulatory Affairs Specialist

Engineer

• Assist in the implementation of corporate policies and procedures relating to quality
• Plan, prepare, and execute calibrations and analyze data to approve equipment and processes
• Collect, statistically analyze calibration data
• Assist in the development, implementation, and documentation calibration activities

Clinical Research Project Manager

Regulatory Affairs Specialist

Calibration Engineer