Customer Complaints Specialist

4 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. The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience in complaint management and processing of event reporting.

Key Responsibilities:

  • Collaborate with clinical, technical, and regulatory employees to determine product event status and MDR reportability
  • Assure 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
  • Maintain complaint and MDR file documentation in accordance with regulatory requirements

Qualifications:

  • Bachelor's degree in chemistry, engineering, or nursing
  • 1-2 years of experience in quality, regulatory, or complaint management

Skills and Abilities:

  • Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry
  • Attention to detail and ability to utilize computers for development of reports
  • Strong proficiency with MS Office tools


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