Customer Complaints Specialist

2 weeks ago


San Diego, California, United States MILLENNIUMSOFT Full time
Job Title: Customer Complaints Specialist

MillenniumSoft is seeking a highly skilled Customer Complaints Specialist to join our team. As a key member of our quality assurance team, you will be responsible for managing and resolving customer complaints in a timely and efficient manner.

Key Responsibilities:
  • Collaborate with clinical, technical, and regulatory employees to determine product event status and MDR reportability
  • Ensure timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products
  • Write and submit eMDR reports to the FDA and Health Canada in strict adherence with 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
Requirements:
  • Bachelor's degree (chemistry, engineering, nursing) strongly preferred
  • 1 to 2 years' experience in Quality, Regulatory or Complaint management is preferred
  • Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry
  • Attention to detail is essential
  • Strong proficiency with MS Office tools to include Word, Excel, PowerPoint and Outlook
What We Offer:

MillenniumSoft offers a dynamic and challenging work environment, competitive compensation, and opportunities for professional growth and development.



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