Clinical Affairs Associate - #1405094

Company Overview

Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position Overview

The Clinical Affairs Associate organizes regulatory information and tracks and controls submissions. Participates in project meetings. Reviews and advises on labeling for compliance with regulatory filings. Reviews product changes for impact on regulatory filings worldwide. Research regulatory issues and provides guidance and advice to colleagues.

What You Will Do

• Provide regulatory guidance to colleagues to ensure subsequent documentation will meet the needs of the regulatory submissions.
• Support preparation of regulatory submissions including, but not limited to US 510ks and European technical files.
• Support regulatory review of customer complaints and/or adverse events from clinical studies to determine if event is reportable.
• Communicate region-specific regulatory requirements to Clinical team leaders and assists with the regulatory strategies to build the regulatory database.
• Manage registration of Argon-sponsored studies in applicable databases in accordance with regulations and internal processes.
• Provide support to marketed products for registration and/or maintenance of Argon’s assets including execution of post-market clinical follow up surveys, marketing initiatives, etc. as assigned.
• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
  
  

Skills For Success

• Bachelor’s Degree in science, math or engineering discipline required.
• 5+ years relevant experience in FDA regulated industry - US Class II products and higher.
• Expertise with MS Office, including Excel, Word, Access, Project, Visio.
• Previous audit training/certification preferred.
• Understanding of current regulatory and clinical requirements governing medical devices, including but not limited to: 21 CFR (e.g., 803, 812, 814, 820, 822, and 830); EU MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.