Quality Complaints Management Specialist - Urgent Need

millenniumsoft • San Diego, CA

12d

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

• 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.
• 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.

Nice To Haves

• Prior work experience with Trackwise Complaint Handling System preferred.
• Prior experience filing eMDRs preferred.

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.

What This Job Offers

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