Enterra Medical, Inc is dedicated to helping more people with chronic gastroparesis live better lives through advancing technology, bolstering clinical science, and accelerating patient access to Enterra Therapy. The FDA approved the Humanitarian Device Exemption for Enterra Therapy in 2000. Over 15,000 people have received Enterra Therapy to help resume everyday activities. In 2022, Enterra Medical assumed commercial responsibility of Enterra Therapy.

Position Summary:

The MDR / Vigilance / IRB Reporting Specialist has responsibility to document and evaluate product feedback and product analysis results for Enterra product complaints to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. This position has responsibility to support regulatory agency reports for continued compliance to FDA and European regulations. This individual performs activities to maintain accurate records of approved IRBs for product distribution under an FDA approved Humanitarian Device Exemption (HDE), monitor complaint activity, ensure timely review of product feedback, product analysis, support formal product investigations, and complaint closure actions

Duties and Responsibilities:

• Main point of contact for the IRB database
• Interaction with customers, clinical research coordinators, and sales force to maintain an accurate IRB database
• Interface with distribution systems to assure product is distributed only to authorized locations
• Apply policies and procedures to comply with FDA and OUS regulations
• Monitors evaluation, processing, and follow-up on adverse event reports
• Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility
• Support timely submission of Medical Device Reports, Vigilance Reports, Annual reports to Institutional Review Boards as required by regulatory agencies
• Interface and collaborate with patient liaisons and other customer support personnel to ensure appropriate collection of complaint information in an efficient and customer focused manner
• Other duties as assigned

Position Requirements:

• Associate degree preferred
• Experience in healthcare or medical device/pharmaceutical industry, safety or clinical data evaluation preferred
• Computer proficiency (Grand Avenue, Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
• Strong attention to detail
• Demonstrated ability for independent work
• Excellent communication skills - both written and verbal

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