Complaint Analyst II

Highly Competitive
  1. Permanent
  2. Analytical Chemistry
  3. United States
Irvine, California
Posting date: 22 May 2019

A leading management consulting firm is advertising a vacancy for a Complaint Analyst II position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its California-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

The Complaints Specialist will be responsible for maintaining the quality processes associated with regulatory reporting and its procedures/controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards. They will review reportable and potentially reportable complaints from incoming calls, faxes, and emails from all areas of the world, whilst ensuring adequate information is received to warrant timely reporting, investigation, and closure of reportable complaints, including sound regulatory reporting decisions/justifications for worldwide reporting. Finally, the Analyst will apply standard practices and procedures, adjust and correlate data, recognize discrepancies in results, and follow operations through a series of related detailed steps and processes.

Job Responsibilities:

  • Overseeing the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.).
  • Ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.
  • Evaluating all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
  • Setting up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services.
  • Escalating critical issues for proper disposition as necessary.
  • Receiving technical guidance on complex problems, but independently determines and develops approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures
  • Ensuring compliance with the company's Quality System policies and procedures, as well as applicable external requirements and standards, including FDA (21 CFR), ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, , Health & Safety Practices, and other applicable standards as pertaining to medical devices.
  • Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
  • Supporting Product Analysis Evaluation if required.

Skills and Requirements:

  • Bachelor's Degree in technical science discipline.
  • At least 2 years of recent experience in a medical device complaint or CAPA team, or an equivalent combination of education and experience.
  • Working knowledge of international standards and regulatory requirements including but not limited to ISO 13485 and 21 CFR Parts 803 and 820.
  • Technical report writing skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Maya Smith at +267-405-6995 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.