Job Description
If you are interested, Please send an updated resume to Anant.K@sunrisesys.com or Bhuvana.K@sunrisesys.com.
Job responsibilities, not limited to: Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints about products Write and submit eMDR reports to the FDA and Health Canada in strict adherence to regulatory requirements and timelines. Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information Maintain complaint and MDR file documentation in accordance with regulatory requirements. Completes global complaint handling and adverse event reporting activities related to products Comply with the site Quality System. Performs other duties as assigned. Education & Experience: Bachelor's degree (chemistry, engineering, nursing) strongly preferred. 1 to 2 years' experience in Quality, Regulatory or Complaint management is preferred. May consider an equivalent combination of education and experience. Knowledge, Skills & Abilities: Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry. Attention to detail is essential. Able to utilize computers for the 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. The ability to work on multiple projects with various disciplines is essential. Ability to multitask in an ever-changing environment. The position requires innovative/critical thinking, the ability to solve problems, and meet deadlines. Strong communication, organization, presentation, and writing skills.
Company Description
Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.