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Medical Device Reporting Specialist Jobs (NOW HIRING)

ConsignMed Inc.

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Clinical Specialist Medical Device

Odessa, TX · On-site

$100 - $150/day

Report customer inquiries, complaints, and service requests within 24 hours of being notified ... for the medical device & pharma space. We match top notch per diem Clinical Specialists with ...

GDIT

Reporting Specialist

Bethesda, MD · Hybrid

$96K - $130K/yr

No Reporting Specialist GDIT is seeking a Reporting Specialist as part of the larger National ... Our benefits package for all US-based employees includes a variety of medical plan options, some ...

Masimo

Clinical Complaint Specialist

Irvine, CA · On-site

$80K - $100K/yr

Job Summary The Clinical Complaint Specialist is responsible for the clinical assessment ... Evaluate complaints for regulatory reportability, including Medical Device Reporting (MDR ...

Masimo

Clinical Complaint Specialist

Irvine, CA · On-site

$80K - $100K/yr

Job Summary The Clinical Complaint Specialist is responsible for the clinical assessment ... Evaluate complaints for regulatory reportability, including Medical Device Reporting (MDR ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Identify and report non-conforming materials or process deviations to supervisors * Maintain a ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Identify and report non-conforming materials or process deviations to supervisors * Maintain a ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

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Medical Device Reporting Specialist information

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How much do medical device reporting specialist jobs pay per hour?

As of Aug 26, 2026, the average hourly pay for medical device reporting specialist in the United States is $31.27, according to ZipRecruiter salary data. Most workers in this role earn between $21.15 and $35.82 per hour, depending on experience, location, and employer.

What is a medical device reporting specialist?

A Medical Device Reporting (MDR) Specialist is responsible for monitoring, analyzing, and reporting adverse events, malfunctions, and product complaints related to medical devices. They ensure compliance with regulatory requirements set by agencies like the FDA or EMA by evaluating incidents and submitting mandatory reports. MDR Specialists work closely with quality, regulatory, and compliance teams to track trends, identify potential safety concerns, and implement corrective actions. Their role is critical in maintaining patient safety and ensuring that medical devices meet regulatory standards.

What are typical daily responsibilities for a medical device reporting specialist?

A Medical Device Reporting Specialist is typically responsible for collecting, investigating, and documenting adverse events or malfunctions related to medical devices. This includes reviewing reports from healthcare providers or customers, analyzing data for regulatory compliance, and preparing accurate submissions to regulatory agencies like the FDA. Specialists often collaborate with engineering, quality assurance, and regulatory affairs teams to gather necessary technical information and resolve open cases. Some days may involve responding to regulatory inquiries or participating in internal audits to improve reporting processes. This role is vital for ensuring products meet safety standards and for minimizing risks to patients and users.

What are the key skills and qualifications needed to thrive as a medical device reporting specialist?

To thrive as a Medical Device Reporting Specialist, you need a background in healthcare or life sciences, attention to detail, and strong analytical and regulatory knowledge. Familiarity with medical device reporting systems such as FDA's MedWatch, adverse event tracking databases, and regulatory submission tools is commonly required, along with certifications like RAC (Regulatory Affairs Certification) being advantageous. Strong communication, critical thinking, and organizational skills are essential for effectively gathering, analyzing, and presenting data. These abilities are vital to ensure regulatory compliance, maintain patient safety, and support smooth and accurate device reporting processes.

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Medical Device Reporting Specialist jobs near you
Infographic showing various Medical Device Reporting Specialist 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 $65,038 per year, or $31.3 per hour.

Medical Device Complaint Specialist

Three Point Solutions

Moundsview, MN • On-site

$24 - $27/hr

Contractor

Re-posted 7 days ago

Job description

Job Title:         Medical Device Complaint Specialist

Client:              Medical Device Manufacturing Company
Location:         Mounds View, MN 55112
Duration:         12 Months (Possible Extension)
Shift:                1st Shift

Job Summary

Entry-level medical device safety and complaint investigation role responsible for intake, documentation, adverse event reporting, MDR submissions, and vigilance activities for Neurovascular products while ensuring compliance with regulatory requirements.

Key Responsibilities

• Review, document, and investigate product complaints
• Process Medical Device Reports (MDRs) and adverse event cases
• Maintain accurate complaint and vigilance records
• Analyze safety and clinical data for reporting purposes
• Ensure compliance with FDA and global regulatory requirements
• Support complaint investigations and follow-up activities
• Collaborate with cross-functional teams and external partners
• Assist with process improvements and quality initiatives
• Prepare regulatory documentation and reports

Core Duties

• Complaint handling & investigation
• Medical Device Reporting (MDR)
• Adverse event processing
• Regulatory compliance support
• Safety data review & analysis
• Documentation & case management

Required Skills

• Critical thinking and decision-making
• Strong attention to detail
• Excellent written and verbal communication
• Investigation and problem-solving skills
• Documentation and record management
• Organization and time management

Preferred Skills

• Medical device industry experience
• Pharmaceutical industry experience
• Complaint handling experience
• Regulatory reporting knowledge
• Quality or compliance exposure
• Clinical data review experience

Technical / Functional Exposure

• Medical Device Reporting (MDR)
• Vigilance & Post-Market Surveillance
• Complaint Investigation
• Adverse Event Reporting (ADE)
• Regulatory Compliance
• Clinical & Safety Data Analysis

Work Environment

• Medical device regulatory and quality environment
• Cross-functional collaboration with quality, regulatory, and clinical teams
• Process-driven and compliance-focused role
• Training and development opportunities for entry-level professionals

Education / Experience

• Bachelor's Degree in Bio-Sciences, Engineering, Life Sciences, or related field required
• Experience in Medical Device, Pharmaceutical, Quality, Regulatory, Clinical, or related industry

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