Associate Regulatory Affairs Specialist

CryoLife • Austin, TX

296d • Remote

About The Position

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.

Requirements

• Bachelor's degree in relevant science or technical discipline and 0-2 years of experience in the medical device, biologics, pharmaceutical, or other regulated industry.
• Ability to effectively manage and prioritize numerous tasks and responsibilities.
• Strong analytical, technical writing, verbal/written communication, organizational, and time management skills.
• Must be flexible and able to adapt easily to changing priorities.
• Willingness to work in a hybrid role (remote and in-office as needed).

Nice To Haves

• Prior regulatory experience or equivalent experience in quality, engineering or operations in a regulated industry.
• Experience working with cross-functional teams.

Responsibilities

• Complete regulatory research, document review, labeling, listing, and submission activities for new product development and existing approved products.
• Under management supervision, team with global partners and international regulatory staffs to provide regulatory documentation and change assessments for existing products.
• Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address questions from regulatory agencies under management supervision.
• Support regulatory compliance activities, including facility site registrations, audits, etc., as needed.
• Provide support to currently marketed products, including review of labeling, promotional material, product changes and documentation for changes.
• Develop proficiency in worldwide regulatory requirements and global medical device standards.
• Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.)
• Maintain and update regulatory processes and procedures and follow all work/quality procedures to ensure quality system compliance, training requirement fulfillment, and high-quality work.
• Uphold ethical behavior consistent with the Artivion, Inc. mission, vision and quality policy.

Benefits

• Competitive pay
• 401(k)
• Medical insurance
• Dental insurance
• Vision insurance
• Employee stock purchase program
• Relocation assistance
• Generous PTO
• Opportunities for growth and development in a supportive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree