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Entry Level Complaint Handling Medical Device Jobs

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 ...

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 ...

Staar Surgical

Product Complaint Associate

Monrovia, CA · On-site

$25 - $32/hr

Maintain complaint files. 3. Coordinate complaint investigations according to complaint handling ... handling complaints and medical device reporting is highly desirable. • Demonstrated ...

STAAR Surgical

Product Complaint Associate

Monrovia, CA · On-site

$25 - $32/hr

Maintain complaint files. 3. Coordinate complaint investigations according to complaint handling ... handling complaints and medical device reporting is highly desirable. • Demonstrated ...

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Entry Level Complaint Handling Medical Device information

What are the key skills and qualifications needed to thrive as an entry level complaint handling medical device specialist?

To thrive in this role, you need a background in life sciences or engineering, strong attention to detail, and familiarity with regulatory standards like FDA or ISO 13485. Proficiency with complaint management systems, database software, and document control tools is typically required. Excellent written communication, critical thinking, and teamwork skills help ensure accurate investigation and reporting of complaints. These abilities are vital to maintain product quality, ensure compliance, and safeguard patient safety in the medical device industry.

What are some common challenges faced in an entry level complaint handling role in the medical device industry?

In an entry-level complaint handling role for medical devices, a common challenge is quickly understanding complex regulatory requirements and accurately documenting each complaint according to strict industry standards. You may also encounter difficulties when liaising between customers, quality assurance, and engineering teams to gather necessary information for investigations. Additionally, learning to prioritize cases based on risk, while maintaining attention to detail and clear communication, is essential for success. Support from more experienced colleagues and access to robust training materials can help you overcome these challenges as you develop your expertise.

What is the difference between Entry Level Complaint Handling Medical Device vs Entry Level Customer Support Medical Device?

AspectEntry Level Complaint Handling Medical DeviceEntry Level Customer Support Medical Device
CertificationsBasic medical device regulations, quality standardsCustomer service skills, product knowledge
Work EnvironmentQuality assurance departments, complaint review teamsCall centers, help desks, online support
Employer & Industry UsageMedical device manufacturers, healthcare companiesMedical device companies, healthcare providers

While both roles involve interaction with medical device users, Complaint Handling Medical Device focuses on investigating and resolving product complaints, ensuring compliance with regulations. Customer Support Medical Device emphasizes assisting customers with product inquiries and technical issues. The former requires knowledge of quality standards, while the latter centers on communication skills. Both roles are essential in maintaining customer satisfaction and product safety within the medical device industry.

What does an entry level complaint handling medical device professional do?

An Entry Level Complaint Handling Medical Device professional is responsible for receiving, documenting, and processing complaints related to medical devices. They ensure that all complaints are recorded accurately, investigate basic issues, and escalate complex cases to senior staff. Their work helps companies comply with regulatory requirements, maintain product quality, and protect patient safety. This role often involves communication with customers, regulatory agencies, and internal teams to resolve issues efficiently.
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Entry Level Complaint Handling Medical Device jobs near you
Infographic showing various Entry Level Complaint Handling Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Medical Device Complaint Specialist

Three Point Solutions

Moundsview, MN • On-site

$24 - $27/hr

Contractor

Re-posted 18 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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