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Medical Device Risk Management Jobs in Rowlett, TX

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Medical Device Risk Management information

See Rowlett, TX salary details

$46.2K

$100.1K

$152.5K

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 Rowlett, TX is $100,091.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,800.00 and $115,700.00 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 Rowlett, TX look for?

The top searched job categories for Medical Device Risk Management jobs in Rowlett, TX are:

What cities near Rowlett, TX are hiring for Medical Device Risk Management jobs?

Cities near Rowlett, TX with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Rowlett, TX as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $100,091 per year, or $48.1 per hour.

Regulatory Affairs Specialist III (Plano, TX)

CEDENT

Plano, TX • On-site

Full-time

Re-posted 12 days ago

Job description

The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices). The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards. Responsibilities (Specific tasks, duties, essential functions of the job) Regulatory Submissions and Compliance: Develop regulatory strategies to achieve market clearance in an effective and efficient manner Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable 510(k) and/or De Novo submissions for FDA Technical documentation for EU MDR compliance International product registration activities to meet business objectives Provide regulatory input to support product labeling Monitor new and changing regulatory requirements and ensure the business understands relevant impacts Lead corrective and preventive action (CAPA) efforts as assigned Product Development Support: Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions Change Control Management: Assess and document regulatory impacts of design changes, manufacturing changes, et al, including related updates to product registrations Audits and Inspections: Support and participate in internal and external audits and regulatory agency inspections QMS Support: Complete QMS training activities and provide regulatory expertise to continuous improvement activities Supporting Lean and Kaizen initiatives Comply with all company policies and procedures Assist with any other duties as assigned Qualifications (Experience and Education) Education: Bachelor of Science degree Experience: 5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices.

Current experience leading multiple successful 510(k) clearances and CE marking is required, and experience with additional global regulatory pathways is preferred Technical Skills: Strong understanding of medical device product life cycle and regulatory requirements. In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR. Knowledge of ISO 14971 risk management for medical devices.

Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis. Understanding of continuous improvement principles. Personal Attributes: Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies.

Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions. High level of attention to detail and accuracy, particularly when preparing regulatory submissions

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About Cedent

Sourced by ZipRecruiter

CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008

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