ZipRecruiter

Log In

1

Medical Device Risk Management Jobs in Kearny, NJ

Intelas

Medical Device Cybersecurity Analyst

New York, NY · On-site

$80K - $95K/yr

Medical Device Cybersecurity Analyst- NY, NY Salary: $80,000- $95,000/yr Other Forms of ... risk management of inventoried connected medical devices * Perform other duties as assigned that ...

New

RWJBarnabas Health

Risk Manager

Newark, NJ · On-site

$95K - $115K/yr

Coordinate notification and follow-up activities related to medical device recall alerts * Educate staff and leadership on risk management principles, event reporting, claims prevention, and loss ...

RWJBarnabas Health

Risk Manager

Newark, NJ · On-site

$95K - $115K/yr

Coordinate notification and follow-up activities related to medical device recall alerts * Educate staff and leadership on risk management principles, event reporting, claims prevention, and loss ...

RWJBarnabas Health

Risk Manager

Newark, NJ

$95K - $115K/yr

Coordinate notification and follow-up activities related to medical device recall alerts * Educate staff and leadership on risk management principles, event reporting, claims prevention, and loss ...

New

RWJBarnabas Health

Risk Manager

Newark, NJ · On-site

$95K - $115K/yr

Coordinate notification and follow-up activities related to medical device recall alerts * Educate staff and leadership on risk management principles, event reporting, claims prevention, and loss ...

next page

Showing results 1-20

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 8, 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

Risk Management Engineer

Stark Pharma Solutions Inc

Piscataway, NJ • Remote

Contractor

Re-posted 17 days ago

Job description

Job Title: Risk Management Specialist

Location: REMOTE

Duration: Long Term

Risk Management Specialists will support remediation workstreams by ensuring appropriate

consideration of product risk throughout retrospective design reviews and documentation updates. The

team will provide expertise to ensure alignment with applicable risk management expectations under

FDA Quality Management System Regulation (QMSR) and ISO 14971.

Responsibilities

  • Provide risk management expertise across remediation workstreams.
  • Review design documentation to ensure appropriate consideration of product risk.
  • Support retrospective evaluation of risk within design documentation.
  • Assist in development of risk-based justifications where documentation gaps exist.
  • Ensure risk considerations are incorporated during documentation updates and remediation activities.
  • Provide guidance on alignment with risk management expectations under QMSR and ISO 14971.
  • Collaborate with cross-functional teams to ensure risk perspectives are appropriately integrated.

Qualifications

  • Experience in risk management within medical device development.
  • Experience supporting remediation initiatives within regulated environments.
  • Familiarity with risk management principles and methodologies.
  • Experience applying or reviewing risk processes aligned with ISO 14971.
  • Familiarity with risk management expectations under FDA QMSR and global regulatory frameworks.
  • Experience reviewing design documentation with risk considerations.