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Complaint Management Medical Device information

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$39K

$68.7K

$97.5K

How much do complaint management medical device jobs pay per year?

As of Jun 13, 2026, the average yearly pay for complaint management medical device in the United States is $68,656.00, according to ZipRecruiter salary data. Most workers in this role earn between $66,000.00 and $69,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Complaint Management for Medical Devices, and why are they important?

To thrive in Complaint Management for Medical Devices, you need a solid understanding of regulatory requirements (such as FDA and ISO standards), quality management systems, and product knowledge, often supported by a degree in life sciences or engineering. Familiarity with complaint handling software, CAPA systems, and documentation tools is typically required, along with experience in root cause analysis. Strong attention to detail, effective communication, and problem-solving abilities are crucial soft skills for investigating and resolving complaints. These skills ensure compliance, patient safety, and continuous product improvement in a highly regulated industry.

What are some common challenges faced in a Complaint Management role within the medical device industry?

Professionals in Complaint Management for medical devices often face challenges such as ensuring compliance with complex regulatory requirements, maintaining accurate documentation, and coordinating timely responses to customer complaints. The role requires effective communication with cross-functional teams—including quality assurance, regulatory affairs, and engineering—to investigate and resolve issues. Balancing thorough investigations with prompt reporting is crucial to meeting both patient safety and regulatory obligations. Additionally, staying updated on evolving regulations and industry standards is essential for ongoing success in this position.

What is the difference between Complaint Management Medical Device vs Quality Assurance Medical Device?

AspectComplaint Management Medical DeviceQuality Assurance Medical Device
CertificationsISO 13485, Medical Device RegulationsISO 13485, Medical Device Regulations
Work EnvironmentCustomer complaints, post-market surveillanceProduct testing, process audits
Employer & Industry UsageMedical device companies, post-market teamsManufacturers, quality departments

Complaint Management Medical Device professionals focus on handling and investigating customer complaints related to medical devices, ensuring compliance and product safety. In contrast, Quality Assurance Medical Device staff oversee overall product quality, conduct audits, and implement process improvements. While both roles require similar certifications and work within the medical device industry, Complaint Management specialists concentrate on post-market issues, whereas Quality Assurance professionals focus on preventing defects during manufacturing.

What is complaint management in the medical device industry?

Complaint management in the medical device industry refers to the process of receiving, documenting, investigating, and resolving complaints related to medical devices. This process ensures that any issues or adverse events reported by users, healthcare professionals, or patients are handled in compliance with regulatory requirements. Effective complaint management helps manufacturers identify potential product problems, improve device safety, and maintain regulatory compliance. It also involves reporting certain complaints to regulatory authorities when required, such as the FDA or European Medicines Agency.
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Complaint Management Medical Device jobs near you

Complaints Management Specialist

millenniumsoft

San Diego, CA • On-site

Contractor

Posted 11 days ago

Job description

Position : Complaints Management Specialist
Location : San Diego, CA
Duration : 12 Months contract
Total Hours/week : 40.00
1st Shift
Description:
  • 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 responsibilities, not limited to:
  • 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 client 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.

Qualifications:
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 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 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.
  • Complaint handling is definitely preferred, but not a deal breaker. Looking for smart, technologically adept specialists that can think critically and multi task in a constantly changing environment.

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