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Complaint Handling Medical Device Jobs (NOW HIRING)

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 · 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 ...

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Complaint Handling Medical Device information

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$39K

$68.7K

$97.5K

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

As of Aug 22, 2026, the average yearly pay for complaint handling 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 is a complaint handling medical device?

A Complaint Handling Medical Device job involves reviewing, investigating, and documenting customer complaints related to medical devices. Professionals in this role ensure compliance with regulatory requirements, analyze complaint trends, and support corrective and preventive actions (CAPA). They collaborate with quality, regulatory, and engineering teams to assess potential risks and improve product safety. This role is essential for maintaining compliance with FDA, ISO 13485, and other regulatory standards.

What are some common challenges encountered in a complaint handling medical device role?

Professionals in Complaint Handling for Medical Devices often face the challenge of investigating complex product issues while adhering to strict regulatory timelines. They must balance thorough analysis with clear documentation, frequently collaborating with cross-functional teams such as engineering, quality assurance, and regulatory affairs. Handling a high volume of complaints and prioritizing cases based on risk or severity also requires strong organizational skills. Successfully overcoming these challenges is essential to ensure product safety, maintain compliance, and support continual improvement efforts within the company.

What are the key skills and qualifications needed to thrive in the complaint handling medical device position, and why are they important?

To thrive in Complaint Handling for Medical Devices, you need knowledge of medical device regulations, experience with complaint investigations, and typically a background in science, engineering, or a related field. Familiarity with quality management systems (QMS), complaint handling databases, and industry standards such as ISO 13485 and FDA 21 CFR Part 820 is crucial. Excellent analytical skills, attention to detail, and clear communication help professionals stand out in this position. These qualifications are vital because they ensure effective complaint resolution, regulatory compliance, and patient safety in a highly regulated industry.

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Complaint Handling Medical Device jobs near you
Infographic showing various Complaint Handling Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $68,656 per year, or $33 per hour.

Medical Device Complaint Specialist

Three Point Solutions

Moundsview, MN • On-site

$25 - $27/hr

Contractor

Re-posted 3 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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