Sr. RA Project Manager

Position Overview

The Sr. Project Manager, Regulatory Affairs, provides functional and technical leadership, develops regulatory strategies and supports organizational objectives. In collaboration with senior RA Management, the role will work directly with the Food and Drug Administration (FDA) and other domestic or international regulatory agencies to obtain and maintain regulatory approvals and ensure compliance for Artivion medical devices and/or tissue products. The individual has department and cross-functional level 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, Marketing, Operations) as a core team member or leader, and will mentor junior staff, cross-functional and matrix teams as appropriate.

Responsibilities:

• 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.
• Establishes and leads technical (functional and cross-functional) and strategic initiatives and works with cross-functional business partners to create and improve internal business processes and maintains current knowledge of the global regulatory landscape to ensure regulatory projects are accomplished to deliver strategic plans on time and within budget.
• Accountable for development and execution of regulatory strategies and submission activities (510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian License, international registrations, including amendments, supplements, renewals, annual reports and responses to requests for additional information) for complex new product development activities and product maintenance for existing approved products.
• Team with global partners and international regulatory staff to provide support for new products/therapies and may support changes to existing products. Establish and maintain positive relationships with stakeholders and team members. Leverage experience and technical knowledge to advance corporate strategies.
• Prepare, review and execute significant product submissions with project stakeholders, advise on strategies and negotiate submission issues with agency personnel. Ensure timely submission approvals and product market release.
• Provide support to currently marketed products, including review of labeling, promotional material, product changes and documentation for changes, facility site registrations, support audits, etc., as needed, to maintain regulatory compliance.
• 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.
• Examine and recommend opportunities within industry to advance Artivion objectives.
• Manage and provide feedback and on-going support to RA functional and staff members for regulatory issues and questions, ensure quality system compliance and high-quality work outcomes.
• Create, maintain and update regulatory processes and SOPs and ensure local site compliance, and support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.)

Qualifications:

Must have:

• Bachelor's degree in science, engineering or related field, with 10+ years of regulatory, quality, and/or compliance experience in medical device or biologics industries.
• Experience with FDA Class II or III devices or experience with 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.
• Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.
• Experience leading cross-functional teams with 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 correspondence, Notified Body interaction, TGA and Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue preferred.
• Excellent written and oral communication skills.
• Willingness to mentor and manage junior staff, delegate tasks, and ensure staff accountability.
• Ability to apply experience to ensure regulatory affairs compliance and interaction