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Medical Device Risk Management Jobs in New York (NOW HIRING)

Jj

Device Safety Officer

Raritan, NJ · On-site

Utilizing their medical / surgical training and deep domain expertise in device risk management, the DSO is the single point of accountability for the medical assessment of device asset risk ...

Intelas

Medical Device Integration Analyst

Manhattan, NY · On-site

$75K - $85K/yr

... Risk Management. The Analyst will also assist in responding to identified medical device vulnerabilities. As a part of a dynamic technical team, Medical Device Integration Analyst will assist with ...

Jj

Manager, Compliance Risk Management

Raritan, NJ · On-site

Experience in medical device quality systems and global regulatory environments. * Priorpeopleleadership or project leadership experience. * Experience with risk management tools, methodologies, and ...

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Medical Device Risk Management information

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$56.3K

$122K

$186K

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

As of Aug 29, 2026, the average yearly pay for medical device risk management in New York is $122,046.00, according to ZipRecruiter salary data. Most workers in this role earn between $98,500.00 and $141,100.00 per year, depending on experience, location, and employer.

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 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 are popular job titles related to Medical Device Risk Management jobs in New York?

For Medical Device Risk Management jobs in New York, the most frequently searched job titles are:

What job categories do people searching Medical Device Risk Management jobs in New York look for?

The top searched job categories for Medical Device Risk Management jobs in New York are:

What cities in New York are hiring for Medical Device Risk Management jobs?

Cities in New York with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you

Device Safety Officer

Raritan, NJ • On-site

Jj
See more jobs at Jjexternal

Full-time

Retirement, PTO

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Purpose:

The Device Safety Officer (DSO) is a specialized role that ensures medical safety excellence at the intersection of pharmaceuticals and medical devices. Utilizing their medical / surgical training and deep domain expertise in device risk management, the DSO is the single point of accountability for the medical assessment of device asset risk throughout the design, development, and post-market lifecycle for assigned programs and products.

As a member of the J&J Innovative Medicine Safety Management Team (SMT) for assigned programs and products, the DSO represents Global Medical Safety as the primary point of accountability for cross-functional device Risk Management Teams (RMT).

The DSO is expected to utilize and remain current in their knowledge of global device regulations, standards, and guidance to support this mission within a pharmaceutical-led portfolio, including but not limited to EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, and ISO 14155/14971/20916.

In addition, the DSO will serve as a subject matter expert in their role for internal consultations, audits/inspections, and other proceedings, and will participate in special projects and initiatives to streamline and optimize device processes and meet key performance metrics.

You will be responsible for:

Evidence-based decision making for the severity of harms as a result of device-associated hazardous situations and associated probabilities of harm.

Documenting, explaining, and defending device risk assessment decisions made, and updating Product Risk Management (PRM) deliverables based on new evidence and inputs from cross-functional peers and stakeholders.

Representing Global Medical Safety at RMTs and quality event meetings convened for device assets.

Review and sign off on device Product Risk Assessments (PRA) and other PRM deliverables requiring medical input.

Leading standardization initiatives, including the development and maintenance of a global harms list.

Ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.

Ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.

Meeting performance and risk metrics for device workflows that support strategic decision-making.

Supporting special projects and initiatives as needed.

Qualifications:

Physician / Surgeon (MD, MBBS, DO, or equivalent), with at least 3 years of postgraduate training and 2 years of clinical practice experience is required.

At least 2 years of experience in the application of risk management to medical devices is required.

An active medical license and board certification in a relevant discipline is strongly preferred.

Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required.

Ability to rapidly assimilate and apply new information for device assets and regulations is required.

Demonstrated ability to leverage AI-enabled tools and technologies to improve decision-making, streamline work processes, and enhance business outcomes.

Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required.

Strong written and verbal communication skills are required.

Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required.

Required Skills:

Preferred Skills:

Clinical Operations, Compliance Management, Compliance Risk, Consulting, Design Mindset, Developing Others, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Quality Control (QC), Research Ethics, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Succession Planning, Surveillance

The anticipated base pay range for this position is :

$199,000.00 - $343,850.00

Additional Description for Pay Transparency:

The anticipated pay range for this role is $199,000 - $343,275.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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