Position : Quality Complaints Management Specialist 

Location : San Diego, CA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Healthcare

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Work hours: 8:30 – 5 M-F

Job Description:

• The Specialist, Clinical Customer Advocacy is responsible for the completion of all tasks associated with complaint management and processing of event reporting, including communication for regulatory compliance with medical device reporting for both domestic and international agency regulations.

Duties and Responsibilities:

• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine and track product event status
• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products
• Write and submit complaint investigation reports into the complaint management system.
• Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information
• Maintain complaint in accordance with regulatory requirements.
• Comply with the site Quality System.
• Performs other duties as assigned.
• Performs other duties as assigned.

Knowledge and Skills:

• Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry.
• Attention to detail is essential.
• Able to utilize computers for development of reports and summary of project experience.
• Strong proficiency with MS Office tools to include Word, Excel, PowerPoint, and Outlook.
• Prior work experience with Trackwise Complaint Handling System preferred.
• Prior experience filing eMDRs preferred.
• Ability to work on multiple projects with various disciplines are essential.
• Ability to multitask in an ever-changing environment.
• Position requires innovative/critical thinking, ability to solve problems and meet deadlines.
• Strong communication, organization, presentation, and writing skills.

Education and Experience:

• Bachelor’s degree (chemistry, engineering, nursing) strongly preferred.
• 1 to 2 years’ experience in Quality, Regulatory or Complaint management is preferred.
• May consider equivalent combination of education and experience.