Regulatory Affairs Specialist

Artivion, Inc.•Austin, TX

7h•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

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.
Other responsibilities as assigned.