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Medical Device Complaints Jobs (NOW HIRING)

Eisai, Inc.

Mgr., Product Complaints (Hybrid)

Raleigh, NC · On-site

$104K - $137K/yr

This role ensures that medical device complaints are consistently captured, appropriately triaged, thoroughly reviewed, and closed in compliance with FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR ...

Eisai

Mgr., Product Complaints (Hybrid)

Raleigh, NC · Hybrid

$104K - $137K/yr

This role ensures that medical device complaints are consistently captured, appropriately triaged, thoroughly reviewed, and closed in compliance with FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR ...

SPECTRAFORCE

Data Entry Associate

Collegeville, PA

Product and medical device complaints Complaints that require expedited processing due to potential compliance issues. Responsible for recording and processing quality complaint information received ...

Spectra force

Data Entry Associate

Collegeville, PA · On-site

$15.75 - $20.50/hr

Qualifications Essential Functions: • Triage all incoming reports to immediately identify the following: • Product and medical device complaints • Complaints that require expedited processing ...

Masimo

Clinical Complaint Specialist

Irvine, CA · On-site

$80K - $100K/yr

Review, evaluate, and process medical device complaints in accordance with applicable regulations, company procedures, and quality system requirements. * Perform clinical assessments of complaint ...

Masimo

Clinical Complaint Specialist

Irvine, CA

$80K - $100K/yr

Review, evaluate, and process medical device complaints in accordance with applicable regulations, company procedures, and quality system requirements. * Perform clinical assessments of complaint ...

ConsignMed Inc.

Be Seen First

Clinical Specialist Medical Device

Odessa, TX · On-site

$100 - $150/day

Report customer inquiries, complaints, and service requests within 24 hours of being notified ... medical device or Operating Room experience, preferred * Gyn/Surg related experience, preferred

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Medical Device Complaints information

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How much do medical device complaints jobs pay per hour?

As of Jul 26, 2026, the average hourly pay for medical device complaints in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Medical Device Complaints Specialist, and why are they important?

To thrive as a Medical Device Complaints Specialist, you need a solid understanding of regulatory requirements (such as FDA and ISO standards), strong analytical abilities, and a background in life sciences or engineering. Familiarity with complaint management systems, quality management software, and relevant certifications like Six Sigma or CAPA process training are typically required. Attention to detail, effective communication, and problem-solving skills are crucial for investigating issues and collaborating with cross-functional teams. These skills ensure accurate complaint handling, regulatory compliance, and continuous product quality improvement.

What are some common challenges faced in a Medical Device Complaints role and how can they be managed?

Professionals in Medical Device Complaints often encounter challenges such as managing high volumes of complaint data, ensuring timely investigations, and maintaining compliance with strict regulatory requirements. To address these, strong organizational skills and attention to detail are essential, as is the ability to effectively communicate with cross-functional teams such as quality assurance, engineering, and regulatory affairs. Staying updated on evolving regulations and using complaint management software can also help streamline processes and ensure accurate reporting.

What is the difference between Medical Device Complaints vs Medical Device Quality Assurance Specialist?

AspectMedical Device ComplaintsMedical Device Quality Assurance Specialist
Primary FocusHandling and investigating complaints related to medical devicesEnsuring overall quality and compliance of medical devices during manufacturing
Required CredentialsTypically requires knowledge of regulations and complaint handling proceduresRequires quality management system knowledge, certifications like ISO 13485
Work EnvironmentCustomer service, complaint investigation teams, regulatory complianceManufacturing facilities, quality assurance departments
Industry UsageUsed by medical device companies to address post-market issuesUsed to maintain product quality and compliance throughout production

Medical Device Complaints focus on managing and investigating issues reported by users post-market, while Medical Device Quality Assurance Specialists oversee the quality systems and compliance during manufacturing. Both roles are essential in ensuring safe, effective medical devices but differ in their primary responsibilities and work environments.

What are medical device complaints?

Medical device complaints are reports or communications from users, patients, or healthcare professionals regarding potential problems, malfunctions, or adverse events associated with a medical device. These complaints may include issues such as device failure, product malfunction, labeling errors, or user injuries. Handling these complaints is crucial for ensuring patient safety and regulatory compliance, as manufacturers are required to investigate and report certain complaints to regulatory bodies like the FDA. Proper complaint management helps improve device quality and can lead to product improvements or recalls if necessary.
More about Medical Device Complaints jobs
What states have the most Medical Device Complaints jobs? States with the most job openings for Medical Device Complaints jobs include:
What job categories do people searching Medical Device Complaints jobs look for? The top searched job categories for Medical Device Complaints jobs are:
Medical Device Complaints jobs near you
Infographic showing various Medical Device Complaints job openings in the United States as of July 2026, with employment types broken down into 61% Full Time, 28% Part Time, and 11% Contract. Highlights an 100% In-person job distribution, with an average salary of $76,384 per year, or $36.7 per hour.
Mgr., Product Complaints (Hybrid)

Mgr., Product Complaints (Hybrid)

Eisai, Inc.

Raleigh, NC • On-site

$104K - $137K/yr

Full-time

Posted 11 days ago

Job description

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Manager, Product Complaints is responsible for the oversight, governance, and continuous improvement of Eisai's medical device complaint handling process. This role ensures that medical device complaints are consistently captured, appropriately triaged, thoroughly reviewed, and closed in compliance with FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR, and Eisai quality system requirements.
The role serves as the single point of entry for all Raleigh site commercial product complaints to ensure data quality and consistency; however, the position only triages and fully manages medical device complaints. This role is accountable for reviewing, challenging, accepting, and approving investigations from the device manufacturer on behalf of Eisai.
This role partners closely with medical information by providing high-quality medical device complaint data, accepted investigation outcomes, and trend analyses to support vigilance and signal management activities as part of the Post-Market Surveillance program (PMS).
Essential Functions:
  • Serve as the single point of entry for all Raleigh site product complaints, ensuring timely, accurate, and complete complaint documentation while following established Eisai procedures for routing all complaints.
  • Triage and classify medical device complaints, including confirmation of device involvement, user error considerations, and potential quality or safety impact.
  • Own and oversee the end-to-end lifecycle of medical device complaints, including intake, triage, investigation oversight, escalation, documentation, and closure. Apply human factors and usability engineering principles to assess whether events are attributable to user error, use related risk, foreseeable misuse, or product quality/design issues.
  • Manage complaint sample handling (shipping, tracking) to external sites for investigation.
  • Review investigation strategies, failure analysis methodologies, root cause determinations, and supporting evidence to ensure investigation adequacy, scientific rigor, and regulatory compliance.
  • Escalate inadequate, delayed, or non-compliant investigations through Quality governance and supplier oversight mechanisms.
  • Establish and monitor medical device complaint metrics, dashboards, and trend analyses (e.g., failure mode, component, lot/batch, time to event).
  • Ensure complaint data effectively informs CAPA, risk management, and product improvement initiatives.
  • Author, own, and maintain SOPs related to Complaint Handling and Oversight
  • Drive continuous improvement initiatives related to complaint handling effectiveness, investigation quality, and compliance.

Requirements:
  • Bachelor's or Master's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmacy, or a related technical field.
  • 5+ years of experience in medical device complaint handling, post market quality, or related quality system roles, required.
  • Medical Device (auto-injector) and combination product experience required.
  • Experience providing oversight of externally performed medical device investigations (e.g., CMOs or device manufacturers) preferred.
  • Hands-on experience with complaint systems compliant with 21 CFR Part 820 (QMSR), ISO 13485, and EU MDR.
  • Prior involvement in medical device recalls or field actions preferred.
  • Strong knowledge of:
    • FDA Medical Device Reporting (21 CFR Part 803)
    • EU MDR vigilance and complaint handling requirements
    • ISO 14971 risk management principles
    • IEC 62366-1 usability engineering
  • Strong cross functional collaboration and stakeholder influence skills.
  • Excellent organizational, time management, and technical writing capabilities.
  • Values aligned with Eisai's mission and patient first culture, including integrity, professionalism, quality, and teamwork.
  • Ability to work a hybrid schedule (a minimum of 3 designated days - T, W, TH - onsite)

Eisai Salary Transparency Language:
The annual base salary range for the Mgr., Product Complaints (Hybrid) is from :$104,900-$137,700
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
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About Eisai

Sourced by ZipRecruiter

Eisai is a global pharmaceutical company (headquartered in Woodcliff Lake, NJ, US), renowned for its innovative research and development in neuroscience and oncology. The primary focus of the company is to provide therapeutic treatments and solutions for diseases like Alzheimer's, cancer, and other neurological disorders. Eisai was founded in Japan in 1941 and has since developed a strong presence across international markets. Eisai's core values center around their philosophy of 'human health care' (hhc), where they aim to make significant and positive contributions to patients and their families' healthcare worldwide.

Company size

1,001 - 5,000 Employees

Headquarters location

Nutley, NJ, US

Year founded

1995

Social media

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