Regulatory Affairs Specialist

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. Our Austin facility comprises a diverse team, including quality engineers, sustaining engineers, production associates, IT professionals, and various other experts dedicated to supporting the production of our On-X Mechanical Heart Valves. 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 Regulatory Affairs (RA) Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions, and obtaining and maintaining approval for products to markets worldwide. Additionally, the RA Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. The RA Specialist will work independently and manage their own regulatory projects.

PRINCIPAL RESPONSIBILITIES:

• Define the 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 staffs to provide regulatory 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.
• Review significant product submissions with project stakeholders 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.
• Support regulatory compliance activities, including facility site registrations, audits, etc., as needed.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Provide feedback and on-going support to product development teams for regulatory issues and questions.
• Ensure personal understanding of all quality policy/system items that are personally applicable.
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.
• Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.)
• Maintain and update regulatory processes and SOPs.

Must have:

• * Bachelor's degree and a minimum of 2 years of regulatory experience or an advanced degree with a minimum of 1 years of regulatory experience.
  * Experience with FDA Class II or III devices or experience with EU Class IIb or III devices.
  * 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.

Preferred:

• Experience with Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue.

ESSENTIAL PHYSICAL REQUIREMENTS:
lifting/carrying X standing bending
pushing/pulling X speaking/communicating twisting
X sitting carrying/balancing
stooping/crouching X seeing
reaching X hearing

We offer competitive pay, 401(k), medical, dental, vision, an employee stock purchase program, relocation assistance, and generous PTO, along with opportunities for growth and development in a supportive work environment