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Overnight Complaint Handling Medical Device Jobs

Masimo

Clinical Complaint Specialist

Irvine, CA · On-site

$80K - $100K/yr

Experience in the medical device, biotechnology, pharmaceutical, diagnostics, or healthcare industry. * Experience with complaint handling, adverse event reporting, post-market surveillance, or ...

Masimo

Clinical Complaint Specialist

Irvine, CA

$80K - $100K/yr

Experience in the medical device, biotechnology, pharmaceutical, diagnostics, or healthcare industry. * Experience with complaint handling, adverse event reporting, post-market surveillance, or ...

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Overnight Complaint Handling Medical Device information

What does an overnight complaint handling medical device professional do?

An Overnight Complaint Handling Medical Device professional is responsible for receiving, documenting, and addressing complaints related to medical devices during overnight shifts. They ensure that all reported issues are logged accurately, assessed for potential safety risks, and escalated according to regulatory requirements. Their role is critical in maintaining compliance with quality standards and ensuring patient safety by facilitating timely investigation and resolution of complaints, even outside of regular business hours.

What are the key skills and qualifications needed to thrive as an overnight complaint handling medical device professional?

To excel in this role, you need a solid understanding of medical device regulations, complaint handling procedures, and often a background in life sciences or biomedical engineering. Familiarity with quality management systems (such as ISO 13485), FDA reporting systems (like MDR), and complaint tracking software is typically required. Strong attention to detail, critical thinking, and effective written communication help ensure accurate documentation and timely resolution of issues. These skills are vital to maintain product safety, regulatory compliance, and customer trust during off-hours support.

What unique challenges might I face working an overnight shift in medical device complaint handling, and how can I prepare for them?

Working overnight in medical device complaint handling can be challenging due to reduced immediate access to on-site colleagues and support teams, requiring strong problem-solving and autonomous decision-making skills. You may also encounter urgent issues from global customers in different time zones, making effective communication and documentation crucial. To prepare, familiarize yourself with escalation protocols, ensure you are comfortable working independently, and establish clear communication channels with your daytime counterparts for seamless case handovers.

What is the difference between Overnight Complaint Handling Medical Device vs Customer Service Representative in Medical Devices?

AspectOvernight Complaint Handling Medical DeviceCustomer Service Representative in Medical Devices
CredentialsTypically requires medical device certifications or training, knowledge of regulatory standardsUsually requires customer service experience, sometimes industry-specific training
Work EnvironmentNight shifts, healthcare or medical device companies, regulated environmentsDay shifts, office or call center settings, healthcare industry
Employer & Industry UsageMedical device manufacturers, healthcare providers, regulatory bodiesMedical device companies, healthcare providers, distributors
Search & Comparison IntentUnderstanding roles related to complaint management during overnight hoursCustomer support roles in medical device industry

While both roles involve communication within the medical device industry, the Overnight Complaint Handling Medical Device position focuses on managing urgent complaints during overnight shifts, requiring specialized knowledge of medical regulations. In contrast, Customer Service Representatives handle general inquiries and support during regular hours, with less emphasis on regulatory compliance.

What cities are hiring for Overnight Complaint Handling Medical Device jobs?

Cities with the most Overnight Complaint Handling Medical Device job openings:

What are the most commonly searched types of Complaint Handling Medical Device jobs?

The most popular types of Complaint Handling Medical Device jobs are:

What states have the most Overnight Complaint Handling Medical Device jobs?

States with the most job openings for Overnight Complaint Handling Medical Device jobs include:

Overnight Complaint Handling Medical Device jobs near you
Infographic showing various Overnight Complaint Handling Medical Device job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Medical Device Complaint Specialist

Three Point Solutions

Moundsview, MN • On-site

$25 - $27/hr

Contractor

Re-posted 11 days ago

Job description

Job Title:         Medical Device Complaint Specialist

Client:              Medical Device Manufacturing Company

Duration:         2 Years (Possible Extension)

Location:         Mounds View, MN 55112

Shift:                1st Shift

Key Responsibilities

  • Review and evaluate product complaints and adverse event reports.
  • Determine Medical Device Reporting (MDR) and Vigilance reporting eligibility.
  • Prepare and submit MDR, Vigilance Reports (VR), and Adverse Drug Experience (ADE) reports.
  • Monitor complaint investigations through closure and ensure timely follow-up.
  • Review product analysis and investigation results.
  • Ensure compliance with FDA and international (OUS) regulatory requirements.
  • Maintain complaint documentation and regulatory records.
  • Analyze clinical and safety data for regulatory reporting.
  • Collaborate with internal teams and external partners to collect complaint information.
  • Support medical device surveillance and post-market vigilance activities.
  • Maintain knowledge of new products, regulations, and reporting requirements.
  • Support continuous improvement of complaint handling and regulatory reporting processes.

Must-Have Requirements

  • Bachelor's Degree in a Science-related field.
  • 1–2 years of experience in Healthcare, Medical Device, Pharmaceutical, Safety, or Clinical Data Evaluation.
  • Strong computer skills (Microsoft Office, SAP, Siebel, Oracle Clinical, or similar systems).
  • Knowledge of complaint handling and adverse event documentation.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • High attention to detail.
  • Ability to work with regulatory documentation and confidential information.

Preferred Qualifications

  • Degree in Nursing, Biology, Pre-Med, Pre-Vet, Biomedical Engineering, or Biomedical Sciences.
  • Clinical or nursing background.
  • Medical Device industry experience.
  • Knowledge of FDA Medical Device Reporting (MDR) requirements.
  • Knowledge of anatomy and physiology.
  • Experience with complaint investigations and post-market surveillance.
  • Experience with regulatory reporting systems.

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