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Manager Fda Consulting Jobs in Texas (NOW HIRING)

DHD Consulting

Deputy Project Manager

Austin, TX · On-site

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 ...

CEDENT

Regulatory Affairs Consultant

Dallas, TX

Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... management standards such as ISO 13485 and FDA QSR (Quality System Regulations). Conduct gap ...

Spruce Infotech

SAP EWM Consultant

Dallas, TX · On-site

... Warehouse Management (EWM), including Advanced EWM capabilities, to act as Consulting Lead to ... Tailor EWM solutions to comply with Life Sciences GxP / validated environments including FDA / EMA ...

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Manager Fda Consulting information

What does a manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

How does a manager in FDA consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.

What are the key skills and qualifications needed to thrive as a manager in FDA consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily employed within companies managing regulatory submissions

While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.

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 Manager Fda Consulting jobs in Texas?

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

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

The top searched job categories for Manager Fda Consulting jobs in Texas are:

What cities in Texas are hiring for Manager Fda Consulting jobs?

Cities in Texas with the most Manager Fda Consulting job openings:

Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in Texas as of August 2026, with employment types broken down into 86% Full Time, 13% Part Time, and 1% Contract. Highlights an 84% Physical, 2% Hybrid, and 14% Remote job distribution.

Medical Device Quality Remediation Consultants (Hybrid)

The FDA Group

Fort Worth, TX • On-site

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.