Artivion, Inc. ยท 1 day ago
Project Manager, Regulatory Affairs
Kennesaw, GA
Full-time
Onsite
Senior Level
5+ years expArtivion, Inc. is a medical device company focused on developing solutions for cardiac and vascular surgeons. The Project Manager, Regulatory Affairs will lead regulatory strategies, ensure compliance for medical devices, and collaborate with global stakeholders to bring products to market efficiently.
Biotechnology
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
Qualification
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
Company
Artivion, Inc.
Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Pat Mackin
President & CEO
Ashley Lee
EVP, COO & CFO
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