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Manager Fda Consulting Jobs in Texas (NOW HIRING)

Nurse Practitioner

Austin, TX · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

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 ...

QA/RA Specialist

Dallas, TX · On-site

  • Medical

  • Dental

  • Vision

  • PTO

... consulting services. Our work supports organizations navigating complex quality and regulatory ... Ensure adherence to regulatory requirements from FDA, EMA, and other global regulatory agencies.

New

Client Services Manager

Houston, TX · Hybrid

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

Pursue and support consulting opportunities and sales of value-added services * Develop proposals ... Understanding of clinical trials, including US-FDA 510(k) / PMA regulatory pathway * Knowledge of ...

Client Services Manager

Houston, TX · On-site

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

Pursue and support consulting opportunities and sales of value-added services * Develop proposals ... Understanding of clinical trials, including US-FDA 510(k) / PMA regulatory pathway * Knowledge of ...

QA/RA Specialist

Dallas, TX · On-site

  • Medical

  • Dental

  • Vision

  • PTO

... consulting services. Our work supports organizations navigating complex quality and regulatory ... Ensure adherence to regulatory requirements from FDA, EMA, and other global regulatory agencies.

New

Client Services Manager

Houston, TX · On-site

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

Pursue and support consulting opportunities and sales of value-added services * Develop proposals ... Understanding of clinical trials, including US-FDA 510(k) / PMA regulatory pathway * Knowledge of ...

QA/RA Specialist

Dallas, TX · On-site

  • Medical

  • Dental

  • Vision

  • PTO

... consulting services. Our work supports organizations navigating complex quality and regulatory ... Ensure adherence to regulatory requirements from FDA, EMA, and other global regulatory agencies.

New

SAP FICO Consultant

Fort Worth, TX · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

With over four decades of experience in managing the systems and workings of global enterprises, we ... FDA, UDI-related impacts, costing traceability). Testing & Quality Assurance Define test approach ...

Health & Safety Manager

Austin, TX · On-site

$85 - $120/hr

Act as a subject matter expert and consultant to manage highly technical HSE subject matters with ... Act as DSV representative for OSHA, EPA, FDA, or other state and federal regulatory agencies and ...

New

IT/OT Consultant

Houston, TX

  • Medical

  • Dental

  • Vision

  • Retirement

Manage IT/OT initiatives and collaborate with client staff * Perform analysis of the architecture ... MSc/MBA in business will be a plus * 4-8 years of experience in IT Consulting (internal or external ...

Showing results 21-40

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 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:

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.

Nurse Practitioner

CCRM Fertility

Austin, TX • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 10 days ago


CCRM Fertility rating

7.7

Company rating: 7.7 out of 10

Based on 18 frontline employees who took The Breakroom Quiz


Job description

Come join CCRM Fertility, a global pioneer in fertility treatment, research, science, specializing in IVF, fertility testing, egg freezing, preimplantation genetic testing, third party reproduction and egg donation. As a member of CCRM Fertility’s diverse team of professionals, you will be a part of helping families grow and changing lives. We take pride in providing our employees with meaningful employment, a supportive culture, and a well-balanced personal & work life alignment. For more information, visit www.ccrmivf.com

Location Address: 5301 Southwest Parkway, Building II, Suite 350, Austin, TX 78735

Department: Clinical


What We Offer Our Team Members:

Generous Paid time-off (PTO) and paid holidays
Medical, Dental, and Vision Insurance

Health benefits eligible the first day of the month following your start date.
401(k) Plan with Company Match (first of the month following 2 months of service)
Basic & Supplement Life Insurance
Employee Assistance Program (EAP)
Short-Term Disability
Flexible spending including Dependent Care and Commuter benefits.

Health Savings Account
CCRM Paid Family Medical Leave (eligible after 1 year)
Supplemental Options (Critical Illness, Hospital Indemnity, Accident)
Professional Development, Job Training, and Cross Training Opportunities


What You Will Do:

Review and interpret medical/social history of gynecological, infertility, and obstetrical patients.

Initiate new patient consultations and manage cycles for basic fertility patients, including those using donor sperm, fertility assessment patients, and fertility preservation patients.
Coordinate new patient consultation, medical, and psychological referrals, as indicated, with appropriate provider and serve as a liaison for third-party providers/agencies.
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 manage and ensure continuity of care.

Prescribe medications within the APP’s scope of practice, and dosage information based on consultation with physician.
Perform / order medical screening (i.e., mammography, ultrasound, pap smears, HSG, etc.) relevant to clinical findings and patient history.

Interpret lab results, order follow-up labs or other necessary testing as required, and collaborate with the physician when abnormal findings are identified.
Document all patient procedures/interactions, review all consents/forms for accuracy, update EMR, and complete necessary

patient billing documentation.
Provide patient education regarding IVF/recipient consults and Lupron consults; conduct patient informational follow-ups as needed.
Train clinical staff on updated patient care, follow-ups, procedures, medication, and coordinate with other departments to ensure high-quality patient care.
Serve as primary POC for pharmaceutical representatives and vendors for OB/GYN/infertility related medications and

equipment.


The Nurse Practitioner works under the supervision of the Medical Director for all clinical care, takes direction from the physician as it relates to specific patient care concerns, and is responsible for the initiation and maintenance of patient care. This Position reports to the Practice Administrator and should function in an independent manner.


GYN procedures:

Evaluate for and manage ovarian hyperstimulation syndrome.
Conduct FDA female/male risk assessments, FDA oocyte donor and gestational carrier physicals, and intrauterine inseminations.
Perform pre-op counseling/physical examination, post-op evaluation, and manage ambulatory GYN complaints throughout patient care.

Complete intrauterine inseminations (IUI), pap smears, wet preps, vaginal cultures, endometrial biopsy, laminaria, and balloon removal.

Care Center specific: Perform HSG, saline sonogram, transvaginal ultrasound, and punch biopsy.


OB procedures:

Assess risks associated with age, conditions, and/or multiple gestation.
Provide nursing education regarding pregnancy and first trimester pregnancy care.
Manage abnormal pregnancy in collaboration with the physician team.


CCRM Embryo Donation Program:

Meet with prospective embryo donors and discuss testing requirements/timeline.
Review embryo testing results, assess embryo quality, approve/disapprove embryo donation, and record in EMR.
Match embryo qualities with recipient needs and notify patient of match made.
Review consent form with patient and ensure completion.
Create medication calendar/schedule for recipient patient.

What You Bring:

Nursing degree from an accredited school of Nursing required.
Current Registered Nurse (RN) License required.
Current Nurse Practitioner Certification/Physician Assistant Certification & Prescriptive Authority required.
Current BLS certification required.
3+ years of experience preferred.
Experience in Women’s Health or fertility is preferred.
Maintain professional standing through continued education/organizational training.
Spanish Speaking a plus


Working Conditions: The physical demands described here are representative of those which should be met, with or without reasonable accommodation (IAW ADA Guidelines), by an employee to successfully perform the essential functions of this job. This job operates in a professional office and clinical setting. This role routinely uses standard office equipment such as computers, including computer keyboards and mice; telephones; photocopiers; scanners; filing cabinets. While performing the duties of this job, the employee is regularly required to communicate with others. The employee is frequently required to sit; will occasionally stand and/or walk; use hands and fingers to grasp, pick, pinch, type; and reach with hands and arms. Employees should have the visual acuity to perform an activity such as: preparing and analyzing data and figures, viewing a computer terminal, extensive reading, and operation of standard office machines and equipment.

CCRM’s Compensation: The salary range represents the national average compensation for this position. The base salary offered will vary based on location, experience, skills, and knowledge. The pay range does not reflect the total compensation package. Our rewards may include an annual bonus, flexible work arrangements, and many other region-specific benefits.

Pre-Employment Requirements: All offers of employment are conditional upon the successful completion of the CCRM Fertility onboarding process, including verification of eligibility and authorization to work in the United States. This employer participates in the E-Verify Program in order to verify the identity and work authorization of all newly hired employees.

Equal Employment/Anti-Discrimination: We are an equal-opportunity employer. In all aspects of employment, including the decision to hire, promote, discipline, or discharge, the choice will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression,

veteran status, or any other status protected under federal, state, or local law.


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