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Medical Device Risk Management Jobs in Apex, NC (NOW HIRING)

... Management is desirable. Knowledge, Skills, and Abilities Customer Service Risk Evaluation Interviewing Skills Investigation Skills Medical Terminology Analyze Data Analyze Trends Risk Analysis Duke ...

Senior Electrical Engineer

Raleigh, NC · On-site

$95K - $123K/yr

Master's Degree of engineering experience in the medical device industry and/or highly regulated ... management and risk analysis techniques, consistent with ISO 14971, applied to medical devices

Senior Electrical Engineer

Raleigh, NC · On-site

$95K - $123K/yr

Master's Degree of engineering experience in the medical device industry and/or highly regulated ... management and risk analysis techniques, consistent with ISO 14971, applied to medical devices

Senior Electrical Engineer

Raleigh, NC

$95K - $123K/yr

Master's Degree of engineering experience in the medical device industry and/or highly regulated ... management and risk analysis techniques, consistent with ISO 14971, applied to medical devices

Principal Electrical Engineer

Morrisville, NC · On-site

$130K - $159K/yr

Demonstrated ability to independently lead and deliver complex medical device hardware development ... Experience with hardware FMEA and risk management per ISO 14971. Job Responsibilities: * Serve as ...

Global Tax Risk Management- Manager

Raleigh, NC · On-site

$73K - $244K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... tax risk management for the entire network. As a Manager, you will inspire and develop your team ... PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation ...

TM Raleigh/Durham NC

Raleigh, NC

  • Medical

  • Dental

  • Vision

  • Retirement

Territory Manager / Medical Device Sales Representative Raleigh/Durham, NC My client is a wearable cardiac therapy company helping protect patients' lives every day. As Territory Manager, you'll own ...

TM Raleigh/Durham NC

Raleigh, NC · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

Territory Manager / Medical Device Sales Representative Raleigh/Durham, NC My client is a wearable cardiac therapy company helping protect patients' lives every day. As Territory Manager, you'll own ...

GRA Device Lead, Raleigh, NC

Raleigh, NC · Hybrid

$148K - $195K/yr

... medical devices and combination products within Neurology, Immunology, and New Medicines ... Provide lifecycle management support to maintain device regulatory compliance. Contribute to ...

GRA Device Lead, Raleigh, NC

Raleigh, NC · On-site

$148K - $195K/yr

... management support to maintain device regulatory compliance. • Contribute to internal regulatory ... Minimum of 10 years of medical device experience in life science and/or pharma. Preferred ...

Executive Director, IT Quality & Compliance

Durham, NC · Hybrid

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... medical device, or biotechnology. * 10 or more years' experience leading/managing teams, developing ... Firsthand experience with AI risk management and awareness of emerging AI regulations * Financial ...

Executive Director, IT Quality & Compliance

Durham, NC · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... medical device, or biotechnology. * 10 or more years' experience leading/managing teams, developing ... Firsthand experience with AI risk management and awareness of emerging AI regulations * Financial ...

Showing results 21-40

Medical Device Risk Management information

See Apex, NC salary details

$39.2K

$85K

$129.5K

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

As of Aug 15, 2026, the average yearly pay for medical device risk management in Apex, NC is $85,001.00, according to ZipRecruiter salary data. Most workers in this role earn between $68,600.00 and $98,300.00 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 job categories do people searching Medical Device Risk Management jobs in Apex, NC look for?

The top searched job categories for Medical Device Risk Management jobs in Apex, NC are:

What cities near Apex, NC are hiring for Medical Device Risk Management jobs?

Cities near Apex, NC with the most Medical Device Risk Management job openings:

Full-time

Re-posted 8 days ago


Duke Health rating

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Job description

At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.
General Description of the Job Class
Occupational Summary:
Initiate, coordinate, and manage all investigational and evaluation activities associated with professional and general liability occurrences and claim pre-litigation files. Negotiate resolution with the authority from the Director. Provide basic and complex preventive risk management assessment of processes, procedures, and programs, including inservice education, consultation, liaison activities, and on-call emergency assistance to providers.
Duties and Responsibilities of this Level
  • Investigate and analyze potential and actual professional liability and general liability exposures in the Health System; evaluate the extent and elements of exposure and recommend appropriate actions for risk mitigation.
  • Investigate, evaluate and document pre-litigation occurrences and claims. Recommend resolution, and complete negotiation of resolution within authority granted by Director. Complete notifications and financial recommendations needed for compliance with tracking and insurer requirements, including insurance carrier notifications, reserve recommendations, and any federal, state, or entity reporting requirements (including SMDA, DataBank, etc.) as necessary.
  • Review, code and investigate occurrence reports; recommend corrective actions based on individual reports or trends. Provide quality assurance and peer review referrals as appropriate.
  • Provide in-service education on risk management topics, both standard basic education and complex focused topics as needed and/or requested.
  • Provide on-call assistance for emergent/urgent risk management issues to all DUHS staff as needed. On-call duties are assigned on a rotation basis when possible.
  • Prepare reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions.
  • Represent the Department of Clinical Risk Management on various DUHS and entity committees as required. Perform other related duties incidental to the work described herein.
  • Required Qualifications at this Level

Education
Work requires a Bachelor's degree in business administration, public policy, hospital administration or a related field to acquire appropriate analytical, communicative and organizational skills. A Bachelor's degree in a clinical field (e.g. nursing, physician's associate) may be substituted if supplemented by additional courses or training in business or a related field (at least one year).
Experience
Work requires a minimum of four years experience in one or more of the following fields: patient care, public policy, health care administration, business administration, legal support or insurance/claims investigation and settlement.
Graduate education beyond the bachelor's degree in hospital administration, business administration, public policy or a related field may be substituted for the required experience on a 1:1 basis.
Degrees, Licensure, and/or Certification
An Associate in Risk Management or Certified Professional in Healthcare Risk Management is desirable.
Knowledge, Skills, and Abilities
Customer Service Risk Evaluation
Interviewing Skills Investigation Skills
Medical Terminology
Analyze Data
Analyze Trends
Risk Analysis
Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

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