What are the responsibilities and job description for the Clinical Customer Advocacy Specialist position at Millenniumsoft?
Position : Clinical Customer Advocacy Specialist
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
Location : San Diego, CA
Duration : 12 Months
Total Hours / week : 40.00
Shift : 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)
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.
Perform 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 Track Wise Complaint Handling System preferred.
Prior experience filing eMDRs preferred.
Ability to work on multiple projects with various disciplines is 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.
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