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Medical Device Risk Management Jobs (NOW HIRING)

Baxter

Senior Risk Engineer

Round Lake, IL

Bachelor's degree in Engineering or related field with 3+ years of progressive experience in medical device risk management or product development, including ownership of complex systems or programs.

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Medical Device Risk Management information

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$51.5K

$111.6K

$170K

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

As of Jun 6, 2026, the average yearly pay for medical device risk management 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 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.
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What cities are hiring for Medical Device Risk Management jobs? Cities with the most Medical Device Risk Management job openings:
What states have the most Medical Device Risk Management jobs? States with the most job openings for Medical Device Risk Management jobs include:
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Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in the United States as of May 2026, with employment types broken down into 3% Locum Tenens, 3% As Needed, 43% Full Time, and 51% Part Time. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $111,556 per year, or $53.6 per hour.
QMS Consultant

QMS Consultant

Katalyst HealthCares & Life Sciences

Austin, TX • On-site

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

QMS Consultant

QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and EU MDR 2017/745, ensuring audit readiness, risk-based compliance, and effective stakeholder communication.

Roles And Responsibilities

  • Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
  • Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and the EU MDR 2017/745.
  • Conduct rigorous onsite or virtual stress-testing of core QMS processes:
  • Management Responsibility & Resource Management
  • Design and Development / Technical Documentation Files
  • Production and Service Provision (Cleanroom, Sterilization, Validation)
  • CAPA, Complaint Handling, and Post-Market Surveillance (PMS)
  • Review Technical Files and Design History Files (DHF) to ensure alignment with BSI expectations.
  • Prepare detailed mock audit reports, classifying findings into Major and Minor nonconformances using Notified Body criteria.
  • Provide a definitive gap analysis report outlining critical vulnerabilities and immediate remediation strategies.
  • Debrief leadership and process owners on audit outcomes, providing actionable guidance on how to interface with BSI auditors.
  • Assess the readiness of subject matter experts (SMEs) through simulated front-room/back-room interview dynamics.

Education And Experience

  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
  • Minimum 8 years of experience in the Medical Device industry, specifically in Quality Assurance or Regulatory Affairs.
  • Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).
  • Proven track record of preparing medical device manufacturers for successful Notified Body audits, specifically with BSI.
  • Deep, current knowledge of ISO 13485:2016, ISO 14971 (Risk Management), and European medical device regulations.
  • Strong analytical, interviewing, and technical report-writing skills.
  • Ability to deliver objective, critical feedback constructively under tight preparation timelines.
  • Former BSI Lead Auditor experience is highly preferred.
  • Hands-on experience managing a front-room/back-room during a live BSI QMS audit.
  • Experience auditing the specific device risk classification and technology relevant to our product portfolio.
  • Familiarity with MDSAP requirements.
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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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