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Fda Consulting Jobs in Texas (NOW HIRING)

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Regulatory Affairs Consultant

Dallas, TX

Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... with global regulations (FDA, EU MDR, Health Canada, TGA, etc.). Advise on the appropriate ...

DHD Consulting

Deputy Project Manager

Austin, TX

Act as a liaison between clients, consultants, subcontractors, and internal teams to ensure clear ... Ensure full compliance with cGMP, FDA, ISPE, ASME BPE, and local building code standards throughout ...

Spruce Infotech

SAP EWM Consultant

Dallas, TX · On-site

As Consulting Lead to partner with client leads for process and solution template governance on a ... Tailor EWM solutions to comply with Life Sciences GxP / validated environments including FDA / EMA ...

synergy

Analytical Chemist

Dallas, TX · On-site

... consulting services. Our work supports the advancement of pharmaceutical products from early ... Ensure laboratory activities meet FDA regulatory requirements and internal quality procedures.

CCRM Fertility

Nurse Practitioner

Austin, TX · On-site

Initiate new egg donor and gestational carrier consultations; complete full work up IAW FDA regulations. Develop and implement patient management plans and collaborate with the physician team to ...

synergy

Analytical Chemist

Dallas, TX · On-site

... consulting services. Our work supports the advancement of pharmaceutical products from early ... Ensure laboratory activities meet FDA regulatory requirements and internal quality procedures.

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How much do fda consulting jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for fda consulting in Texas is $48.92, according to ZipRecruiter salary data. Most workers in this role earn between $20.38 and $64.95 per hour, depending on experience, location, and employer.

What is an FDA consulting?

An FDA Consulting job involves providing expert guidance to businesses seeking regulatory approval for their products from the U.S. Food and Drug Administration (FDA). Consultants help companies navigate complex FDA regulations, ensure compliance, and prepare necessary documentation for submissions. They may work with pharmaceuticals, medical devices, food, and biotech industries. Their role includes strategy development, risk assessment, and communication with the FDA to facilitate approvals and avoid compliance issues.

What does an FDA consultant do?

As an FDA Consultant, your day might involve reviewing regulatory documentation, preparing submissions for FDA approval, and advising clients on compliance strategies. You’ll often attend meetings with cross-functional teams including R&D, quality assurance, and legal experts to ensure alignment on regulatory requirements. Consultants also stay updated on changes in FDA guidelines, draft correspondence to regulatory agencies, and address client questions or concerns. This dynamic role requires adaptability and strong collaboration skills to manage multiple projects and effectively support clients through all stages of the regulatory process.

What skills and qualifications are needed for FDA consulting?

To thrive in FDA Consulting, you need expertise in regulatory affairs, a deep understanding of FDA guidelines, and often a degree in life sciences or a related field. Familiarity with regulatory submission systems such as eCTD, knowledge of GxP standards, and certifications like RAC (Regulatory Affairs Certification) are valuable. Strong communication, analytical thinking, and project management skills set outstanding consultants apart. These competencies are essential to effectively guide clients through complex regulatory landscapes and ensure successful product approvals.

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

The most popular types of Fda Consulting jobs in Texas are:

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

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

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

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Fda Consulting jobs near you
Infographic showing various Fda Consulting job openings in Texas as of August 2026, with employment types broken down into 1% Internship, 85% Full Time, 9% Part Time, and 5% Contract. Highlights an 83% Physical, 6% Hybrid, and 11% Remote job distribution, with an average salary of $101,762 per year, or $48.9 per hour.

Medical Device Quality Remediation Consultants (Hybrid)

The FDA Group

Fort Worth, TX

Full-time, Part-time

Posted 3 days ago

New

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.