Project Manager, Regulatory Affairs na Artivion, Inc.

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 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 Objective:

The Project Manager, Regulatory Affairs, provides technical leadership and implements regulatory strategies that deliver organizational objectives. The RA Project Manager will be responsible to obtain and maintain regulatory approvals and compliance for medical devices and/or tissue products. This role will collaborate with global stakeholders (e.g. R&D, Quality, Clinical, Marketing, Operations) as a core team member, and participate in cross-functional or matrix teams. They are responsible for ensuring products meet regulatory requirements, managing the regulatory approval process, and collaborating with regulatory agencies. This role often involves leading cross-functional teams, managing projects and developing regulatory strategies to bring products to market safely and efficiently.

Responsibilities:

• Support complex technical projects through considerable initiative and critical thinking, effective decision-making skills, with the ability to balance multiple competing priorities and escalate issues when critical risks arise. Project management skills applied to all assignments.
• Supports cross-functional technical and strategic initiatives and works with cross-functional business partners to improve internal business processes and maintains current knowledge of the US, EU and international regulatory landscape to ensure regulatory projects meet organizational expectations and plans.
• Accountable for the execution regulatory strategies and global 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.
• Review significant product submissions with project stakeholders and may 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 inspections/audits, etc.
• Team with global partners and international regulatory staff to provide support for new products/therapies and changes to existing products. Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address questions from regulatory agencies. Ensure positive relationships with stakeholders and team members.
• Maintain advanced to expert proficiency in worldwide regulatory requirements. Build relationships with agency personnel and industry leadership.
• Collaborate with RA personnel to implement process improvements to internal regulatory documentation and procedures.
• Collaborate with colleagues to provide feedback and work toward solutions for regulatory issues and questions, ensure quality system compliance and high-quality work outcomes.
• Support the creation, maintenance of regulatory processes and SOPs and support local site and/or product compliance. Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.) and lead action items, activity or closure as required.
• Identify and resolve regulatory compliance issues and develop corrective action plans.
• Role may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
• Writing and review of pre-market and post-market submissions.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Provide effective guidance to functional, cross-functional partners and internal teams.
• Maintain effective rapport with regulatory staff, internal and external customers.

Qualifications:

Required:

• Bachelor's degree in science, engineering or related field, with 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 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.
• Ability to effectively manage and prioritize numerous projects in a fast-paced environment. Project management experience.
• 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.
• Experience participating in cross-functional teams.
• Excellent written and oral communication skills.
• Ability to apply experience to ensure regulatory affairs compliance and interaction.