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Medical Devices Risk Management Jobs (NOW HIRING)

Intellectt INC

Must have deep experience building and maintaining complete risk management files for complex medical devices. Key Responsibilities * Assess and remediate the overall Risk Management File for the ...

Mercyhealth

$94K - $151K/yr

Identify and report those occurrences as required by the Safe Medical Devices Act. * Assist director of risk management with insurance and claim management programs when necessary. * Work closely ...

Mercyhealth

Manager of Risk Management

Janesville, WI · On-site

$94K - $151K/yr

Identify and report those occurrences as required by the Safe Medical Devices Act. * Assist director of risk management with insurance and claim management programs when necessary. * Work closely ...

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Medical Devices Risk Management information

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$51.5K

$111.6K

$170K

How much do medical devices risk management jobs pay per year?

As of Jun 15, 2026, the average yearly pay for medical devices risk management in the United States is $111,556.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,000.00 and $129,000.00 per year, depending on experience, location, and employer.

What is the highest paying risk management job?

In the field of medical devices risk management, senior roles such as Risk Management Directors or Chief Risk Officers typically have the highest salaries, often exceeding six figures. These positions require extensive experience, certifications like ISO 14971, and leadership skills, reflecting their strategic importance and responsibility within organizations.

How much does a risk manager get paid?

A risk manager in the medical devices industry typically earns between $80,000 and $130,000 annually, depending on experience, location, and certifications such as ISO 14971 or ISO 13485. Senior risk managers or those in high-demand regions can earn higher salaries, often exceeding $150,000.

What is risk management in medical devices?

Risk management in medical devices involves identifying, evaluating, and controlling potential hazards throughout the device's lifecycle to ensure safety and effectiveness. Professionals in this field use standards like ISO 14971 and perform risk assessments to minimize harm to patients and users. It is a critical part of regulatory compliance and quality assurance in medical device development.

What are the main challenges faced by professionals in Medical Devices Risk Management, and how are they typically addressed?

Professionals in Medical Devices Risk Management often face challenges related to keeping up with evolving regulatory requirements, managing cross-functional communication, and ensuring comprehensive risk assessments throughout the product lifecycle. Navigating frequent updates to standards such as ISO 14971 and integrating feedback from engineering, clinical, and quality teams can be complex. To address these challenges, risk managers rely on robust documentation practices, regular team training, and close collaboration with regulatory affairs and product development teams to ensure compliance and patient safety.

What is medical devices risk management?

Medical devices risk management is the systematic process of identifying, evaluating, controlling, and monitoring risks associated with the use of medical devices throughout their lifecycle. It aims to ensure that any potential harm to patients or users is minimized by implementing appropriate risk control measures. This process is guided by international standards such as ISO 14971 and is essential for regulatory compliance and patient safety. Risk management activities begin during the device design phase and continue through manufacturing, post-market surveillance, and product retirement.

What are the key skills and qualifications needed to thrive as a Medical Devices Risk Management professional, and why are they important?

To excel in Medical Devices Risk Management, you need a solid understanding of regulatory standards (such as ISO 14971), engineering principles, and risk assessment methodologies, often supported by a degree in engineering, life sciences, or a related field. Familiarity with risk management software, quality management systems (QMS), and relevant certifications like Certified Quality Engineer (CQE) or Regulatory Affairs Certification (RAC) is typically required. Strong analytical thinking, attention to detail, and effective communication skills help professionals identify risks and collaborate across departments. These competencies are crucial for ensuring product safety, regulatory compliance, and successful market access.

Is healthcare risk management a good career?

Healthcare risk management, including roles in medical devices risk management, is a growing field that involves identifying and mitigating risks to ensure patient safety and regulatory compliance. It requires knowledge of industry standards, risk assessment tools, and often certifications such as RAC or CRMP. The career offers stability, opportunities for advancement, and the chance to impact healthcare quality positively.

What is the difference between Medical Devices Risk Management vs Medical Devices Quality Assurance?

AspectMedical Devices Risk ManagementMedical Devices Quality Assurance
CertificationsISO 14971, RACISO 13485, RAC
Work EnvironmentRegulatory, R&D, ComplianceManufacturing, Compliance, Inspection
Industry UsageRisk assessment, mitigation planningProduct quality, process control

Medical Devices Risk Management focuses on identifying and mitigating risks associated with medical devices, ensuring safety and compliance. Medical Devices Quality Assurance emphasizes maintaining product quality through standards and inspections. While both roles collaborate to ensure device safety, risk management is proactive in risk assessment, whereas quality assurance concentrates on quality control throughout production.

Infographic showing various Medical Devices Risk Management job openings in the United States as of June 2026, with employment types broken down into 45% Full Time, and 55% Part Time. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $111,556 per year, or $53.6 per hour.
Project Lead /Onsite coordinator (Medical Devices, sustaining engineering, Risk management)

Project Lead /Onsite coordinator (Medical Devices, sustaining engineering, Risk management)

blackapple

Raynham, MA

Contractor

Posted 5 days ago

Job description

Company Description

Blackapple Solutions Ltd (BSL) was founded in 2004 with the mission to provide best-in-class IT consultancy services across the globe. We are a specialist IT consultancy offering services through our consultants/experts on a contingency basis in the UK, Europe, USA and Asia Pacific. We work with a portfolio of high profile multinational clients across all sectors.


Job Description

Role: Project Lead /Onsite coordinator (Medical Devices, sustaining engineering, Risk management)

Duration: 6-12 Months plus

Work location: Raynham, MA 02767

No of open positions: 1

Hiring Mode (TP /FTE): TP

 Visa: Any

Experience Level: 5-10 years

Educational qualification: Bachelor in Mechanical OR Biomedical Engg.

How many level of internal interview (TP1/TP2/Both): 2 rounds (one telephonic, one Telephonic /Skype).

Mandatory Domain (Put "NO" if domain is not must.): Medical Devices Industry Domain.

Required Skills and experience:

1) Coordinate with Offshore team for sustaining engineering activities like:

- Engineering change requests

- product information support for regulatory

- CAD modeling

- Drawing update / creation

- Test method and protocol writing

- Vendor coordination for prototyping / testing

2) Work on Risk management files updates for DFMEA, RMP and RMR to comply with ISO 14971 2012 standards

3) Meet with cross functional team members to review and finalize the risk management files and release them in PLM. 

4) Function as a liaison between HCL and Client for all base business activities. 

5) CAD software's: AutoCAD 2012, UG NX6. (Preferred)



Additional Information

All your information will be kept confidential according to EEO guidelines.

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