Complaints Management Specialist

millenniumsoft • San Diego, CA

22h

About The Position

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.

Requirements

• 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.
• 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.
• 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.
• Looking for smart, technologically adept specialists that can think critically and multi task in a constantly changing environment.

Nice To Haves

• Prior work experience with Trackwise Complaint Handling System preferred.
• Prior experience filing eMDRs preferred.
• Complaint handling is definitely preferred, but not a deal breaker.

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 client 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level