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Medical Devices Risk Assessment Jobs (NOW HIRING)

Legend Biotech USA, Inc.

$81.04K/yr

Legend Biotech USA, Inc. seeks Risk Assessment Specialist in Raritan, NJ to: conduct Quality Risk ... Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that ...

Legend Biotech US

Risk Assessment Specialist

Raritan, NJ · On-site

$81.04K/yr

Legend Biotech USA, Inc. seeks Risk Assessment Specialist in Raritan, NJ to: conduct Quality Risk ... Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that ...

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Medical Devices Risk Assessment information

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$51.5K

$111.6K

$170K

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

As of May 29, 2026, the average yearly pay for medical devices risk assessment 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 are the key skills and qualifications needed to thrive in Medical Devices Risk Assessment, and why are they important?

To thrive in Medical Devices Risk Assessment, you need a solid background in biomedical engineering or a related scientific field, combined with knowledge of regulatory requirements such as ISO 14971. Familiarity with risk management tools, failure mode and effects analysis (FMEA), and regulatory submission systems is typically required. Attention to detail, analytical thinking, and effective communication are vital soft skills for clearly documenting and presenting risk findings. These competencies ensure that medical devices meet safety standards, minimize patient risk, and achieve regulatory approval.

What are some common challenges faced by professionals in Medical Devices Risk Assessment, and how can they be overcome?

Professionals in Medical Devices Risk Assessment often encounter challenges such as keeping up with rapidly changing regulatory requirements, effectively communicating risk findings to cross-functional teams, and managing complex technical documentation. Staying up-to-date with global standards (like ISO 14971) and participating in regular training can help address regulatory shifts. Developing strong communication skills is essential for ensuring that risk mitigation strategies are understood and implemented by engineering, quality, and clinical teams. Additionally, utilizing robust documentation tools and processes streamlines the risk management workflow and ensures compliance during audits.

What is medical devices risk assessment?

Medical devices risk assessment is the process of identifying, evaluating, and mitigating potential risks associated with the use of medical devices. It involves analyzing how a device might fail, the likelihood and severity of harm, and implementing controls to minimize patient and user risks. This process is essential for regulatory compliance and ensures the safety and effectiveness of medical devices throughout their lifecycle.

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

AspectMedical Devices Risk AssessmentMedical Devices Quality Assurance
Primary FocusIdentifying and evaluating potential risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, regulatory compliance knowledgeISO 13485, quality management system expertise
Work EnvironmentRisk analysis, safety evaluations, documentationQuality audits, process validation, documentation
Industry UsageRisk management during device development and post-marketQuality control during manufacturing and post-market

While both roles are essential in the medical device industry, Medical Devices Risk Assessment focuses on identifying and mitigating potential safety risks, whereas Medical Devices Quality Assurance emphasizes maintaining product quality and compliance throughout the manufacturing process.

Infographic showing various Medical Devices Risk Assessment job openings in the United States as of May 2026, with employment types broken down into 40% Full Time, and 60% Contract. Highlights an 80% In-person, and 20% Remote job distribution, with an average salary of $111,556 per year, or $53.6 per hour.

Risk Assessment Specialist

Legend Biotech USA, Inc.

$81.04K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 days ago

Job description

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel).

Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech USA, Inc. seeks Risk Assessment Specialist in Raritan, NJ to: conduct Quality Risk Assessments (QRM per ICH Q9) for manufacturing processes, QC systems, and equipment, applying methodologies such as FMEA, HACCP, HAZOP, and Pareto analysis; develop, execute, and review validation master plans, cleaning validation, & method transfer protocols; prepare & review technical documentation; collaborate with QA, QC, Manufacturing, Engineering, and R&D teams; analyze data from risk assessments and validation studies, identify gaps, & recommend actions; track & report progress on risk assessment activities; provide subject matter expertise on ICH Q9 Quality Risk Management, FDA, and cGMP compliance; perform related duties as assigned to maintain compliance with FDA, ICH, and GMP standards.Req.BS degree in Biology, Biotechnology, Chemistry, Eng'g, or related technical field (foreign equiv. acceptable) and 12 mos.

exp. as Risk Assessment Specialist, Project Mgr., Data Analyst, or related occ. Req skills: Risk assessment tools such as FMEA,FTA, Pareto analysis, HAZOP and/or HACCP.

Travel: less than 5% as needed, monthly. Salary: $81,037/yr. E-Mail CV to Legend Biotech USA, Inc.

at talent.acquisition@legendbiotech.com.The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location.

The company reserves the right to modify this range as needed and in accordance with applicable laws.Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.

We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.Pay Range (Base Pay): $81,037—$81,037 USDPlease note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.EEO StatementIt is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.For information related to our privacy notice, please review: Legend Biotech Privacy Notice. Salary: . Date posted: 05/19/2026

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