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Medical Device Risk Management Jobs in Kearny, NJ

Jefferies

AVP, Liquidity Risk Management

Manhattan, NY

$150K - $175K/yr

Team The Global Risk Management team is based across the New York, London, Frankfurt, and Asia ... medical condition, physical or mental disability, marital status, domestic partner status, sex ...

Jefferies

AVP, Liquidity Risk Management

Manhattan, NY · On-site

$150K - $175K/yr

Team The Global Risk Management team is based across the New York, London, Frankfurt, and Asia ... medical condition, physical or mental disability, marital status, domestic partner status, sex ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Kearny, NJ

Medical Device Risk Management information

See Kearny, NJ salary details

$53.8K

$116.6K

$177.7K

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

As of Aug 14, 2026, the average yearly pay for medical device risk management in Kearny, NJ is $116,640.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,100.00 and $134,900.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in medical device risk management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

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

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a medical device risk management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.

What cities near Kearny, NJ are hiring for Medical Device Risk Management jobs?

Cities near Kearny, NJ with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you

Senior Manager Medical Device Safety, Pharmacovigilance

Us tech Solutions

Whippany, NJ • On-site

Contractor

Re-posted 16 days ago

Job description

Company Description

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website http://www.ustechsolutions.com/.We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you

Job Description

Title: Senior Manager Medical Device Safety, Pharmacovigilance

Duration: 12 Months

Location: Whippany, NJ 07981

 

Job Description:

The Senior Manager Medical Device Safety (MDS) carries out global Pharmacovigilance (PV) business processes and analyses/trends safety data sets related to complaint handling, regulatory reporting and clinical development for Company medical devices and combination products. The Senior Manager MDS is an expert who provides safety oversight and content contributions to design control, clinical evaluations, vigilance reporting to authorities, trending and post-marketing surveillance for Company Pharmaceutical and Consumer Health medical devices and combination products worldwide.

Position summary:

The incumbent provides counsel as PV medical device subject matter expert to ensure that an effective vigilance, post-marketing surveillance (PMS) and trending systems are implemented and maintained which conforms with global requirements/laws. The Senior Manager MDS works cross-functionally to generate solutions and implement process standards consistent with device industry best practices. The incumbent is a strong problem solver and communicator with a solid understanding of global regulations and standards.

The incumbent will be responsible for the production and accuracy of medical device analysis, interpretation of results and content contributions to PMS and Vigilance activities.

Position duties & responsibilities:

Provide content input to Project teams for designing, planning and conducting analyses of safety data for the assessment of medical device safety and performance.

Provide content input to the post-marketing surveillance (PMS) program activities including, PMS system documentation, PMS planning and report management.

Provide content input, develop and execute PMS trending methodologies, analysis, written contributions and trend report preparations.

Responsible for monitoring, analyzing and applying trending methodologies to the vigilance data submitted to Health Authorities (e.g MDRs).

Responsible for the production and accuracy of medical device analysis and interpretation of results.

Independently review large data sets and prepare reports for submission the Health Authorities under strict timelines and resolved respective queries regarding product safety.

Qualifications

Requirements/Preferences

Education Requirement(s):

Bachelor's Degree in Engineering, Mathematics or Life-science Discipline with 4 years of professional experience in medical devices or similar sector

Skill & Competency Requirements:

Strong scientific application of statistical methods used for evaluating complaint trends and establishing thresholds for routine trend reviews (e.g. human factor, malfunction, user interface and user safety)

Background in medical device trending/signal detection and heavy statistical analysis experience.

Able to develop and administer management information systems for track and trending.

Strong analytical and technical skills that include data collection, analysis and required report generation

Strong communication skills and ability to work both, independently and cross-functionally with Quality, Regulatory, Marketing and other applicable functions within the business

Working understanding of medical device regulations and industry standards globally specifically 21 CFR 820, 803, ISO 13485, and euMDR 2017/745

Preferences:

The individual should be comfortable working in both office/virtual settings and independently.

Additional Information

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

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About US Tech Solutions

Sourced by ZipRecruiter

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

Industry

It services

Company size

1,001 - 5,000 Employees

Headquarters location

Jersey City, NJ, US

Year founded

2000

Social media

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