Senior Clinical Field Assurance Specialist (Remote)

Overview

Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.

Job Scope and Purpose:

This position is responsible for providing clinical/medical insight and guidance into the customer complaint handling process for the purpose of ensuring compliance with US and international regulatory compliance and complaint handling/device reporting requirements.  This position also is responsible for the timely completion of assigned activities related to regulatory compliance support activities worldwide.

Responsibilities

• Responsible for the review, analysis, and summation of medical records and images (e.g., CT) provided in conjunction customer complaints, for inclusion into investigational reports for primarily non-escalated case events.
• Recognition and confirmation of reported and unreported failure modes, as observed in medical records or imaging studies.
• Utilizes department software to document expected clinical results.  
• Supports the Adjudication process, as needed (report writing, meeting preparation, etc.)
• Participation in the decision making, development, and/or review process related to Medical Device Reporting (MDR) and/or Vigilance or other international reporting.
• Collaborates with Patient Safety Director as needed or as requested.
• Supports regulatory body interface related to inquiries associated with adverse event reporting.
• Provides clinical and technical assistance and training of other Field Assurance department employees.
• Supports Principal Clinical Field Assurance Specialist with activities related to new and revised labeling, risk management, quality management, and both internal corporate and external audits, and other projects as needed.    
• Perform other duties as assigned by Principal Clinical Field Assurance Specialist, Field Assurance Department manager or supervisor.

Qualifications

Education:

• Registered Nurse (RN) or other applicable clinical/medical license or degree.

Experience:

years of related work experience, including:

• Minimum of 3 years of medical device experience (Class II/III) or a combination of clinical and medical device experience and a minimum of 5 years of other experience in a medical field.
• Some knowledge with regulatory reporting, quality systems and relationship to business.
• Ability to facilitate and provide leadership concerning investigational activities.
• Must demonstrate technical writing ability.
• Good interpersonal skills including ability to interact with high degree of diplomacy.
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
• Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
• Effective problem solving techniques and excellent applied thinking skills.
• Strong communication and organization skills required.
• Expertise in Microsoft Office applications and charting programs. #LI-KH1