Job Description

Description:

For many roles at this client, assignment is contingent upon the Employer of Record's receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, weekly testing for COVID-19 may be available instead of vaccination. Requests for accommodation will be considered pursuant to applicable law.


a pay rate of $37.18/hour and a bill rate of $47.23/hour.


Work hours: 8:30 - 5 M-F


Remote with some onsite as needed, Must be local


"For many roles at this client, assignment is contingent upon the Employer of Record's receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, weekly testing for COVID-19 may be available instead of vaccination. Requests for accommodation will be considered pursuant to applicable law."


Specialist 2, Complaint Management


Job Description Summary
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.
Job Description
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.

Job Tags

Hourly pay, Work experience placement, Local area, Remote work

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