What are the responsibilities and job description for the Associate Regultory Affairs Specialist position at Artivion?
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 Associate Regulatory Affairs (RA) Specialist is responsible for assessment of device and tissue product changes for regulatory implications and for performing regulatory activities in support of implementing these device changes (e.g., labeling and quality system implementation). The Associate RA Specialist is also responsible for supporting activities related to PMA annual reports, Canadian license renewals and maintaining required facility and state licensing/registrations. Additionally, the Associate RA Specialist will provide regulatory labeling support to ensure labeling compliance. The Associate RA Specialist will work independently with management oversight.
PRINCIPAL 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.
QUALIFICATIONS:
• 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)
Preferred:
• Prior regulatory experience or equivalent experience in quality, engineering or operations in a regulated industry.
• Experience working with cross-functional teams.
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.
