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Medical Device Consulting Jobs in Texas (NOW HIRING)

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Regulatory Affairs Consultant

Dallas, TX · On-site

We are seeking a highly skilled and detail-oriented Regulatory Consultant to join our dynamic team in the medical device sector. This role will provide expert guidance on navigating complex ...

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$19

$46

$90

How much do medical device consulting jobs pay per hour?

As of Sep 3, 2026, the average hourly pay for medical device consulting in Texas is $46.43, according to ZipRecruiter salary data. Most workers in this role earn between $32.69 and $55.53 per hour, depending on experience, location, and employer.

What does a medical device consultant do?

A Medical Device Consultant provides expertise to companies developing, manufacturing, or marketing medical devices. They help navigate regulatory requirements, ensure compliance with FDA or EU MDR guidelines, conduct quality assessments, and offer strategic advice on product development. Consultants may also assist with clinical trials, risk management, and market entry strategies. Their goal is to help companies bring safe and effective medical devices to market efficiently while meeting industry regulations.

What are some typical daily responsibilities for professionals in medical device consulting?

Day-to-day tasks for Medical Device Consultants often include advising clients on regulatory strategy, preparing submissions for compliance agencies, assessing product safety and efficacy data, and coordinating with cross-functional teams such as R&D, quality assurance, and marketing. You may also conduct audits, lead training sessions, and assist clients in navigating clinical trial requirements or post-market surveillance. Collaboration and regular communication with client stakeholders are essential, as is staying current on evolving industry standards. This dynamic role provides exposure to diverse projects and the opportunity to make a tangible impact on the development and approval of innovative medical technologies.

What are the key skills and qualifications needed to thrive in medical device consulting?

To thrive in Medical Device Consulting, you need a strong background in biomedical engineering, regulatory knowledge, and experience with product development or commercialization, often supplemented by a relevant degree and industry certifications. Expertise with FDA regulations, ISO standards, clinical trial management systems, and common project management tools is highly valued. Exceptional problem-solving, client communication, and adaptability are crucial soft skills for success. These competencies are vital to effectively guide clients through compliance, market entry, and product lifecycle challenges in a complex, high-stakes industry.

How to become a medical device consultant?

To become a medical device consultant, individuals typically need a background in biomedical engineering, healthcare, or related fields, along with experience in medical device development, regulatory compliance, or quality assurance. Earning certifications such as ISO 13485 Lead Auditor or Regulatory Affairs Certification can enhance credibility, and strong project management and communication skills are essential for success in this role.

What are the most commonly searched types of Medical Device Consulting jobs in Texas?

The most popular types of Medical Device Consulting jobs in Texas are:

What are popular job titles related to Medical Device Consulting jobs in Texas?

For Medical Device Consulting jobs in Texas, the most frequently searched job titles are:

What job categories do people searching Medical Device Consulting jobs in Texas look for?

The top searched job categories for Medical Device Consulting jobs in Texas are:

What cities in Texas are hiring for Medical Device Consulting jobs?

Cities in Texas with the most Medical Device Consulting job openings:

Medical Device Consulting jobs near you
Infographic showing various Medical Device Consulting job openings in Texas as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $96,577 per year, or $46.4 per hour.

Medical Device Quality Remediation Consultants (Hybrid)

The FDA Group

Fort Worth, TX

Full-time, Part-time

Posted 14 days ago

Job description

Medical Device Quality Remediation Consultants

Location: North of Fort Worth, TX
Work Arrangement: Primarily Onsite / Hybrid Flexibility
Duration: Initial 3-month engagement with potential extension to 6+ months
Openings: 2 Consultants
Start: ASAP / Within the next few weeks
Schedule: Full-time preferred; qualified part-time consultants may also be considered

Position Overview

We are seeking two experienced Medical Device Quality Remediation Consultants to support a quality systems remediation initiative at a medical device organization in Texas.

The consultants will provide hands-on support addressing CAPA and complaint backlogs, FDA remediation activities, quality and regulatory records, and implementation of FDA Quality Management System Regulation (QMSR) requirements.

This engagement requires professionals who can move beyond high-level strategy and actively drive remediation activities through completion. The ideal consultants will be able to identify root causes, develop practical and sustainable corrective actions, and work collaboratively with site personnel to strengthen the overall Quality Management System.

Key Responsibilities

  • Drive investigation, remediation, and closure of open and aging CAPAs.
  • Address existing complaint-handling backlogs and support timely closure of complaint records.
  • Evaluate and improve complaint-handling processes to promote sustainable compliance.
  • Perform and/or support root-cause investigations and development of effective corrective actions.
  • Support remediation activities resulting from FDA inspection observations.
  • Assist with quality and regulatory record management and remediation.
  • Support implementation and integration of FDA QMSR requirements into the existing Quality Management System.
  • Ensure remediation activities align with applicable FDA requirements and ISO 13485.
  • Identify systemic quality issues and develop practical corrective actions that address underlying causes rather than short-term fixes.
  • Collaborate with Quality, Regulatory, Operations, and other cross-functional stakeholders to drive remediation activities to completion.

Required Qualifications

  • Significant medical device industry experience.
  • Strong working knowledge of ISO 13485.
  • Strong knowledge of 21 CFR Part 820 and FDA QMSR requirements.
  • Demonstrated hands-on experience with CAPA remediation and closure.
  • Strong complaint handling and complaint investigation experience.
  • Experience supporting remediation following FDA inspections and observations.
  • Experience with quality records and regulatory documentation.
  • Strong root-cause analysis, investigation, and problem-solving capabilities.
  • Ability to develop sustainable, compliant solutions and effectively drive them through implementation.
  • Comfortable working in a hands-on consulting environment with significant interaction with site personnel.

Work Arrangement

This engagement will require frequent onsite presence in Texas. Some administrative and documentation activities may be completed remotely when appropriate.

Local candidates are preferred; however, travel can be accommodated for highly qualified consultants who are not located in the area.

Ideal Candidate

The ideal consultant is a seasoned medical device Quality Systems/Remediation professional with substantial hands-on experience in CAPA, complaints, FDA remediation, ISO 13485, and FDA QMSR/21 CFR Part 820.