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Medical Devices Risk Assessment Jobs (NOW HIRING)

LanceSoft Inc

Medical Writer I

Raritan, NJ

The applicant will write Product Risk Assessment documents for Pharmaceutical Products and require specific experience in Risk assessments of combination products and/or medical devices. The ...

Managed Staffing

Biocompatibility Scientist

FL · Remote

$145 - $150/hr

The ideal candidate has strong expertise in biocompatibility test strategies, chemical characterization, toxicological risk assessment, and regulatory compliance for medical devices. Key ...

SKYLAND TRAIL

Part Time Risk Assessment Clinician

Atlanta, GA · On-site

$53.50K - $70.60K/yr

... in symptoms, risk, or safety concerns at their current level of care; assess the need for ... Provide monitoring and support for residential clients transferred to the ER for medical evaluation

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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 30, 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.
Medical Writer I

Medical Writer I

LanceSoft Inc

Raritan, NJ

Contractor

Posted 21 days ago

Job description

Company Description

Pharmaceutical Company.

Job Description

Job Description: 

The applicant will write Product Risk Assessment documents for Pharmaceutical Products and require specific experience in Risk assessments of combination products and/or medical devices. The applicant should have experience using risk management methodologies, tools, incorporate appropriate data and information, and conduct risk calculations. The applicant must understand pharmaceutical and/or device manufacturing processes, design controls, and be able to lead and conduct FMEAs. Specific experience with user/design/process FMEAs for medical devices is desirable. A minimum of Five (5) years experience is required. The applicant should be proficient in Microsoft Word, Excel, Visio, Microsoft Project and have experience with documentation systems. The applicant must have experience in leading and facilitating teams to finalize reports with approvals per standard operating procedures. 


The incumbent will work with medical, technical, manufacturing, and quality groups to develop Product Risk Assessments by conducting risk analysis for pharmaceutical products. Job Responsibilities include: 

Collate appropriate and pre-populating the document based on product information, patient/user information, and other supporting documents. 

(the incumbent should have the ability to search these documents, understand the process and extract required information) 

Ensure proper formatting, proof read, and route for approval in documentation system. 

Maintain and update project status in Microsoft Project, excel. 


Key Decisions: 

Participates in decisions and provides input and prepares product risk management reports regarding the adequacy, accuracy, interpretation, and clarity, and final decisions made by the project team. 

Consults with appropriate groups (as required) regarding the acceptability of documentation 


Key Competencies: 

Project Management 

Organization and Time Management 

Communication (Verbal, Written, and Interpersonal) 



Qualifications

Education/Experience Requirements: 


Bachelor's degree in Chemistry, Pharmacy or a related science field plus 4-6 years of relevant experience industrial experience in the healthcare industry 


OR MS/PhD/Pharm.D. plus 3-4 years of pharmaceutical industrial experience 


Minimum of 1-2 years of technical writing experience for manufacturing related activities is mandatory 


Experience working in the Pharmaceutical manufacturing industry (preferably in Technical Services, Operations, manufacturing plant or Research & Development or QA, knowledge of pharmaceutical development processes, cGMPs and regulatory requirements are required. 


Excellent English, writing and oral presentation skills is mandatory 


Prior experience with Pharmaceutical Industry is mandatory 


Prior experience managing projects is preferred 




Job Description: 


Write technical materials, such as SOP's, appendices 


Additional Information

Duties and Responsibilities: 

Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology. 


Maintain records and files of work and revisions 


Edit, standardize, or make changes to material prepared by other writers or establishment personnel 


2+ years experience as a Technical Writer 


2+ years primary role writing user documentation for a variety of products, prepared as part of an integrated team 

Proofing/preparation of documentation

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About LanceSoft

Sourced by ZipRecruiter

Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Herndon, VA, US

Year founded

2000

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