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Medical Device Reporting Jobs (NOW HIRING)

Medical Device Rep

Sarasota, FL · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... based reports, market share & usage reports, etc,) during sales calls as assigned; * Educate ...

Medical Device Rep

Santa Barbara, CA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... based reports, market share & usage reports, etc,) during sales calls as assigned; * Educate ...

Medical Device Rep

Carlsbad, CA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... based reports, market share & usage reports, etc,) during sales calls as assigned; * Educate ...

Medical Device Rep

Baton Rouge, LA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... based reports, market share & usage reports, etc,) during sales calls as assigned; * Educate ...

Identify and make sound decisions regarding medical device reporting to regulatory agencies. * Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory ...

Be Seen First

Report problems or concerns with quality, processes, equipment, materials and labor to ... Preferred: - GMP knowledge - Medical device manufacturing experience. - Microscope experience ...

New

Be Seen First

Maintain accurate territory forecasting, sales reports, and pipeline management in Salesforce ... Prior medical device, technical product, or travel sales experience a plus. * Experience building ...

Experience with Medical Device Reporting (MDR) and FDA regulations (21 CFR 803) * Experience preparing and submitting MDRs, including FDA Form 3500A * Knowledge of complaint handling requirements (21 ...

In-depth knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. * Ability to prioritize multiple projects to ...

Generate precise diagnostic reports for review by the attending MD. * Facilitate enrollment and ... to the relevant medical personnel. * Manage the device clinic database and oversee patient ...

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Medical Device Reporting information

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How much do medical device reporting jobs pay per hour?

As of Jul 16, 2026, the average hourly pay for medical device reporting in the United States is $19.62, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $21.15 per hour, depending on experience, location, and employer.

What is the difference between Medical Device Reporting vs Medical Device Technician?

AspectMedical Device ReportingMedical Device Technician
Required CredentialsRegulatory knowledge, often a background in healthcare or regulatory affairsTechnical skills, certifications in medical equipment maintenance or biomedical technology
Work EnvironmentRegulatory agencies, healthcare compliance departmentsHospitals, clinics, biomedical equipment service centers
Employer & Industry UsageUsed by medical device manufacturers, healthcare providers, and regulatory bodiesEmployers include hospitals and biomedical service companies
Common Search & Comparison IntentUnderstanding regulatory roles in medical device safetyTechnical maintenance and repair of medical devices

Medical Device Reporting focuses on regulatory compliance and reporting adverse events, while Medical Device Technicians handle the maintenance and repair of medical equipment. Both roles are essential in the medical device industry but serve different functions within healthcare and regulatory environments.

What are the key skills and qualifications needed to thrive in Medical Device Reporting, and why are they important?

To excel in Medical Device Reporting, you need a solid understanding of regulatory requirements, data analysis, and healthcare compliance, often supported by a degree in life sciences or a related field. Familiarity with regulatory databases such as FDA’s MAUDE, electronic reporting systems, and quality management software is typically required. Strong attention to detail, analytical thinking, and effective written communication help ensure accurate and timely reporting. These skills are critical for maintaining regulatory compliance, protecting patient safety, and supporting product quality in the medical device industry.

What are some typical challenges faced by professionals in Medical Device Reporting, and how can they be managed?

Professionals working in Medical Device Reporting often encounter challenges such as managing tight regulatory deadlines, ensuring complete and accurate documentation, and staying current with evolving global reporting requirements. Effective time management, attention to detail, and regular training on regulatory updates are essential for success in this role. Collaboration with quality assurance, regulatory affairs, and clinical teams also helps ensure timely and compliant submissions, minimizing the risk of non-compliance.

What is medical device reporting?

Medical device reporting is the process by which manufacturers, importers, and device user facilities notify regulatory authorities, such as the FDA, about certain adverse events and product problems involving medical devices. This reporting system helps monitor the safety and effectiveness of medical devices once they are on the market. The information collected can lead to recalls, safety alerts, or other actions to protect public health.
More about Medical Device Reporting jobs
What cities are hiring for Medical Device Reporting jobs? Cities with the most Medical Device Reporting job openings:
What states have the most Medical Device Reporting jobs? States with the most job openings for Medical Device Reporting jobs include:
Infographic showing various Medical Device Reporting job openings in the United States as of July 2026, with employment types broken down into 75% Full Time, 18% Part Time, and 7% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $40,813 per year, or $19.6 per hour.
Complaint Evaluation Engineer

Complaint Evaluation Engineer

Applied Medical

Rancho Santa Margarita, CA • On-site

$72K/yr

Full-time

Medical, Life, Retirement, PTO

Re-posted 22 days ago


Applied Medical rating

8.0

Company rating: 8.0 out of 10

Based on 23 frontline employees who took The Breakroom Quiz


Job description

Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions.
Position Description
Position Overview: The Complaint Evaluation Engineer plays a critical role in Applied Medical's post-market quality and patient safety efforts by investigating returned medical devices and evaluating real-world product performance. This hands-on, laboratory-based engineering role focuses on device teardown, functional and mechanical testing, and recreation of reported product issues to determine root cause and support continuous improvement. Working closely with cross-functional engineering and quality teams, the complaint evaluation engineer contributes to regulatory compliance, technical documentation, and post-market surveillance activities in alignment with Food and Drug Administration standards, International Organization for Standardization (ISO) 13485 requirements, and Medical Device Reporting expectations. This position is well-suited for engineering professionals seeking experience in medical device investigation, failure analysis, and post-market quality engineering.
Key Responsibilities
  • Perform complaint evaluations and investigations by conducting visual, mechanical, and functional assessments of returned medical devices to evaluate real-world product performance.
  • Execute root cause analysis activities by disassembling devices, recreating reported issues, and applying structured problem-solving methodologies to identify underlying causes.
  • Conduct hands-on laboratory testing and troubleshooting using test fixtures, measurement tools, and simulated clinical-use conditions to validate investigative findings.
  • Prepare technical documentation and reports that clearly summarize test methods, results, conclusions, and recommendations in accordance with FDA, ISO 13485, and Medical Device Reporting requirements.
  • Collaborate cross-functionally with research and development, manufacturing, quality, and clinical development teams to communicate findings and support post-market regulatory activities.
  • Support continuous improvement initiatives by contributing to enhancements in test methods, investigative processes, and documentation practices.
  • Participate in training and professional development to apply feedback constructively and strengthen technical and analytical capabilities.
  • Success in This Role Looks Like
  • Delivering accurate and thorough investigations that identify root cause and support patient safety and product quality.
  • Producing clear, compliant technical reports that meet post-market regulatory and quality system expectations.
  • Effectively collaborating with cross-functional engineering teams to communicate findings and escalate product concerns.
  • Consistently applying structured problem-solving approaches to complex medical device performance issues.
  • Contributing to process improvements that enhance complaint evaluation efficiency, consistency, and technical rigor.

Success in This Role Looks Like:
  • Delivering accurate and thorough investigations that identify root cause and support patient safety and product quality.
  • Producing clear, compliant technical reports that meet post-market regulatory and quality system expectations.
  • Effectively collaborating with cross-functional engineering teams to communicate findings and escalate product concerns.
  • Consistently applying structured problem-solving approaches to complex medical device performance issues.
  • Contributing to process improvements that enhance complaint evaluation efficiency, consistency, and technical rigor.

Position Requirements
The following skills and attributes are required:
  • Work onsite in a highly collaborative engineering and laboratory environment
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related field
  • Minimum of one year of experience in a regulated industry, such as medical device, pharmaceutical, laboratory, aerospace, or strong internship and lab experience
  • Demonstrate strong problem-solving abilities, critical thinking, and a root-cause-focused mindset
  • Ability to take and apply feedback constructively
  • Effective written and verbal communication skills
  • Proficient with spreadsheets, word processing, and technical documentation tools
  • Strong organizational skills and the ability to manage multiple investigations simultaneously
  • Comfortable performing hands-on testing, troubleshooting, and mechanical/electrical evaluation of devices
  • Comfortable handling, inspecting, and testing returned medical devices that have been used in clinical and surgical environments, in accordance with safety and biohazard handling procedures

Preferred
The following skills and attributes are preferred:
  • Experience with failure analysis, complaint investigations, or reliability testing in a regulated environment.
  • Familiarity with post-market regulatory systems, including Medical Device Reporting, corrective and preventive action processes, and quality management system requirements.
  • Understanding of laboratory testing protocols and test equipment used in mechanical or electrical evaluation.
  • Comfortable handling, inspecting, and testing returned medical devices that have been used in clinical and surgical environments, in accordance with safety and biohazard handling procedures.
  • Experience working in an FDA-regulated or ISO 13485-certified organization.
  • Technical writing experience, including preparation of engineering reports or regulatory documentation.
  • Strong analytical capability with an ability to understand integrated mechanical and electrical systems.

Benefits
  • Competitive compensation range: $71000 - $80000 / year (California).
  • Comprehensive benefits package.
  • Training and mentorship opportunities.
  • On-campus wellness activities.
  • Education reimbursement program.
  • 401(k) program with discretionary employer match.
  • Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.
Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.
All compensation and benefits are subject to plan documents and written agreements.
Equal Opportunity Employer
Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

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