Regulatory Affairs Specialist (Hybrid - Austin, TX)

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,400 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details, visit our website at www.artivion.com.

Position Objective:

The Regulatory Affairs (RA) Specialist is responsible for supporting day-to-day manufacturing, preparing U.S. and international submission content, and obtaining and maintaining approval for products to markets worldwide based on direction from RA management. Additionally, the RA Specialist is responsible for assessment of regulated product changes for regulatory implications and for performing regulatory activities in support of implementation. The RA Specialist will work independently and manage their own regulatory projects.

Responsibilities:

• Support manufacturing site needs to meet local objectives and maintain regulatory compliance.
• Provides support for product regulatory compliance maintenance activities for approved products.
• Responsible to maintain compliance for marketed products, including review of labeling, promotional material, product change assessments and documentation for changes.
• Support regulatory commercialization activities, including listing and authorization within the enterprise resource system and/or other related databases.
• Support regulatory compliance activities, including facility site registrations, audits, etc., as needed. Work with cross-functional teams and subject matter experts to maintain regulatory compliance.
• Team with international regulatory colleagues to provide regulatory support for changes to existing products. Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address inquiries from international regulatory agencies.
• Align with RA leadership on the reviews needed for significant product submissions with project stakeholders. Author accurate and complete submission content with support from management. May support leadership with addressing submission questions from external agencies.
• Provide feedback and on-going support to product teams for regulatory questions.
• Generates and executes regulatory or compliance activities under management direction. Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.)
• May support new product development activities in cooperation with senior RA colleagues.
• Understand the regulatory strategy for products and execute the defined submission related activities (which may include international registrations, including renewals, annual reports and responses to requests for additional information) for product maintenance for existing approved products.
• Maintain awareness/have a beginner to intermediate understanding of worldwide regulatory requirements; maintain awareness of agency relationship and ensure RA leadership is prepared with sufficient information to support relationships with external agency personnel.
• Provide basic project management techniques for task management and deliver to defined plans.
• Ensure understanding of all quality policy/system items that are applicable.
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.
• Maintain and update regulatory processes and SOPs as directed. Provide input on improvements to processes to RA leadership and support implementation as requested.
• Comply with 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.

Other responsibilities as assigned.

Qualifications:

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 medium to high risk, FDA Class II or III devices or experience with EU Class IIb or III devices. May include 510(k), IDE, PMA, EU/CE Technical Documentation Files, or Canadian License.
• 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.
• International work experience.

Benefits:

• Comprehensive Medical, Dental, and Vision
• Life Insurance
• Supplemental Benefits
• 401(k) with both Traditional and Roth options available
• Employee Stock Purchase Plan (ESPP)
• 10 Paid Company Holidays
• Competitive PTO plan
• Tuition Reimbursement

Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.