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Consultant, Customer Advocacy - Clinical

Apply Now Job ID R-348125 Date posted 10/07/2019

Locations

San Diego, California

Job Description Summary

The Consultant, Customer Adovocacy-Clinical role is responsible for medical device post-market surveillance / complaint handling functions. The role includes addressing customer experiences or questions received directly from customers or those escalated through the organization. Responsible for the completion of all tasks associated with complaint handling including: initiation or review of reported events in the complaints database, communication with customers to obtain relevant event information, assess reportability and severity of the event and documentation for regulatory compliance and optimal root cause resolution, regulatory reporting (US – MDR and Canada MDPR), resolving issues and preparing customer closure letter responses. Additionally, provides clinical expertise/troubleshooting for internal and external customers when requested.

Job Description

Duties & Responsibilities

  • Ensure complaint file documentation and regulatory reporting decision activities s are conducted in accordance with applicable regulations and department/company policies. 
  • Ensure timely follow-up with customers and company representatives for reported issues.
  • Ensure complaint files are accurate and complete and in line with good documentation practices.
  • Ensure medical device reports are submitted within FDA and Health Canada timeframes and company policy.
  • Demonstrate sound independent decision making in regards to medical device reporting and other functions relating to the investigation of product complaints. Asks questions of team leaders / management as needed.
  • Provide or facilitate clinical expertise/troubleshooting for customers as appropriate.
  • Collaborate with manager and/or department RNs to assess the severity of complaints and understand the typical clinical use to provide input to the Technical investigation for optimal root cause resolution as needed. 
  • In concert with the department manager and escalation teams, strategize to direct the efforts to ensure infusion customer satisfaction.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

QUALIFICATIONS

Education & Experience

  • Bachelor’s degree in Nursing. Will consider similar clinical license or degree (e.g.: LVN). 
  • 2+ years of clinical experience is required; preferrably in a Critical Care Unit or Emergency Department. Knowledge of the use of infusion pumps and equipment is preferred. 
  • 1+ years of experience with medical device complaint handling / post-market surveillance / medical device regulations or experience in a similar regulated environment preferred. Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry preferred.

Knowledge, Skills & Abilities

  • Critical thinking skills.
  • Ability to solve problems and to meet multiple deadlines within a fast paced environment.
  • Excellent writing skills, knowledgeable of good documentation practices.
  • Ability to work on multiple projects with various disciplines. 
  • Able to utilize computers for development of reports and summary of project experience including word processing and spreadsheet computer applications such as Microsoft Word, PowerPoint and Excel.
  • Ability to read, analyze, and interpret common scientific and technical journals, and legal documents. 
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 
  • Ability to effectively present information to management, ancillary departments, and/or customers.
  • Ability to apply clinical and technical skills to regulatory functions.
  • Provide support for internal quality audits of complaint files / MDR documentation, as well as external audits/inspections from Regulatory Bodies as requested.
  • Flexibility and excellent organizational skills to manage/adapt to competing priorities and volume of tasks.

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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