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Freelance 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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Freelance Complaint Handling Medical Device information

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

AspectFreelance Complaint Handling Medical DeviceFreelance Quality Assurance Medical Device
CertificationsISO 13485, Medical Device RegulationsISO 13485, Quality Management System Standards
Work EnvironmentCustomer feedback, post-market surveillanceProcess audits, compliance checks
Employer & Industry UsageMedical device companies, regulatory bodiesManufacturers, certification bodies
Search & Comparison IntentHandling complaints, post-market issuesEnsuring quality, compliance processes

While both roles involve working within the medical device industry and require knowledge of ISO 13485, complaint handling focuses on managing customer feedback and post-market issues, whereas quality assurance emphasizes maintaining compliance and improving manufacturing processes. Understanding these differences helps professionals choose the right freelance opportunity based on their skills and interests.

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Freelance Complaint Handling Medical Device jobs near you
Infographic showing various Freelance 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.

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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