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Complaint Management Specialist
Ref No.: 20-00577
Location: San Diego, California
Our client, a leading medical technology company is looking for a Complaint Management Specialist. This is for an initial duration of 12 months and is located in San Diego, CA
 
Job Description:
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 and company representatives to obtain relevant event information, assess reportability and severity of the event and documentation for regulatory compliance and optimal root cause resolution, regulatory reporting drafting (US – MDR and Canada MDPR), and preparing customer closure letter responses.

Duties & Responsibilities
  • Ensure complaint file documentation and regulatory reporting decision activities 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 ready for submission within FDA and Health Canada timeframes and company policy.
  • Demonstrates sound independent decision making in regards to medical device reporting and other functions relating to the investigation of product complaints.
  • Recognizes when to ask questions of team leaders / management as needed for appropriate intake questions.
  • Facilitate / refer to appropriate individuals when troubleshooting of events is required / requested.
  • Collaborate with manager and/or department RNs to assess the severity and reportability of complaints.
  • Collaborate with manager and/or department RNs to ascertain appropriate questions for regulatory reports and technical returned product investigations 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, Biomedical Engineering or other life science degree with equivalent complaint handling experience required.
  • Minimum of 3+ years of experience with medical device complaint handling / post-market surveillance / medical device regulations or experience in a similar regulated environment.
  • Working knowledge of QA, Regulatory, Quality Compliance in a medical device industry required.
  • Knowledge of infusion pumps / infusion therapy preferred.
  • Ability to read, analyze, and interpret common complaints, basic medical terminology.

Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com / neha.T@sunrisesys.com / bharath.S@sunrisesys.com.  Thank You.