Noctrix Health, Inc.

Complaint Support Specialist

Noctrix Health, Inc.

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $55,000 - $75,000 per year

Job Level

Mid-LevelSenior

About the role

  • Manage and resolve complaints related to medical devices as liaison between Therapy Support and Quality Assurance
  • Receive and review complaints related to medical devices
  • Investigate complaints by gathering relevant information, analyzing data, and conducting root cause analysis
  • Communicate directly with customers to solicit information, address concerns, and provide updates on complaint resolution
  • Serve as a liaison between Therapy Support and Quality departments to optimize customer satisfaction and maintain regulatory compliance
  • Ensure complaint investigations are complete, accurate, and closed in a timely manner
  • Collaborate with cross-functional teams – including Therapy Support, Quality, Regulatory, and Product – to resolve complaints
  • Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 820 and ISO 13485
  • Prepare for and participate in internal and external audits
  • Contribute to cross-functional process improvement initiatives

Requirements

  • Bachelor’s degree preferred in a relevant field such as biomedical engineering, life sciences, or related area; relevant work experience may be considered in lieu of a degree
  • 2+ years of experience in an FDA-regulated environment (drugs, biologics, medical devices, or related products)
  • 3+ years of experience communicating directly with patients or medical device customers
  • Detailed knowledge of ISO 13485 and GMP regulations governing medical device manufacturing
  • Strong analytical and problem-solving skills
  • Excellent verbal communication and interpersonal skills
  • Compassion, empathy, and patience when communicating with customers
  • Attention to detail and ability to manage multiple tasks simultaneously
  • Superior written communication and documentation skills, including presentations, spreadsheets, and reports
  • Ability to lead meetings and build consensus among cross-functional teams
  • Sound judgment with the ability to exercise independent discretion in execution of duties