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Fda Jobs in Raleigh, NC (NOW HIRING)

UNC-Chapel Hill

FDA IND-IDE Specialist

Chapel Hill, NC · On-site

$30/hr

Position Summary The temporary FDA IND/IDE Specialist is responsible for the organization, coordination, review, and submission of regulatory documents supporting Investigational New Drug (IND ...

Medasource

GMP Compliance Investigator

Durham, NC · On-site

This individual will play a key role in maintaining compliance with FDA regulations and applicable accreditation standards by leading investigations, authoring quality documentation, and partnering ...

Carolina CoPacking

Bottle Room Line Lead

Henderson, NC · On-site

$85 - $110/hr

Maintain knowledge of FDA, USDA, SQF, BRC guidelines. * Oversee Production, assist in the development and management of production schedules. * Manage day-to-day production procedures. * Monitor ...

Carolina CoPacking

Bottle Room Line Lead

Henderson, NC · On-site

$15.50 - $19.75/hr

Maintain knowledge of FDA, USDA, SQF, BRC guidelines. * Oversee Production, assist in the development and management of production schedules. * Manage day-to-day production procedures. * Monitor ...

Carolina CoPacking

Bottle Room Line Lead

Henderson, NC · On-site

$15.50 - $19.75/hr

Maintain knowledge of FDA, USDA, SQF, BRC guidelines. * Oversee Production, assist in the development and management of production schedules. * Manage day-to-day production procedures. * Monitor ...

Eightelevengroup

GMP Compliance Investigator

Durham, NC · On-site

$90 - $120/hr

This individual will play a key role in maintaining compliance with FDA regulations and applicable accreditation standards by leading investigations, authoring quality documentation, and partnering ...

Revlon Corporate

Director, Quality Control

Oxford, NC · On-site

This role is responsible for ensuring timely, accurate, compliant testing and release of raw materials, bulk product, packaging materials, labels, and finished goods in support of FDA-regulated ...

Euromed Pharma Us Inc

Director of Quality US

Raleigh, NC · On-site

$110K - $130K/yr

Ensure compliance with FDA, cGDP requirements and applicable regulations for wholesale distribution acting as Responsible Person * Maintain compliance with the Drug Supply Chain Security Act (DSCSA ...

Euromed Pharma Us Inc

Director of Quality US

Raleigh, NC · On-site

$110K - $130K/yr

Ensure compliance with FDA, cGDP requirements and applicable regulations for wholesale distribution acting as Responsible Person * Maintain compliance with the Drug Supply Chain Security Act (DSCSA ...

Euromed Pharma Us Inc

Director of Quality US

Raleigh, NC · On-site

$110K - $130K/yr

Ensure compliance with FDA, cGDP requirements and applicable regulations for wholesale distribution acting as Responsible Person * Maintain compliance with the Drug Supply Chain Security Act (DSCSA ...

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Fda information

See Raleigh, NC salary details

$13

$38

$74

How much do fda jobs pay per hour?

As of Sep 5, 2026, the average hourly pay for fda in Raleigh, NC is $38.03, according to ZipRecruiter salary data. Most workers in this role earn between $23.70 and $47.40 per hour, depending on experience, location, and employer.

What does an FDA professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What qualifications do you need to work for the Food and Drug Administration?

To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or public health. For certain positions, advanced degrees or specialized certifications may be required, along with relevant work experience and knowledge of regulatory processes and compliance standards.

What are the most commonly searched types of Fda jobs in Raleigh, NC?

The most popular types of Fda jobs in Raleigh, NC are:

What are popular job titles related to Fda jobs in Raleigh, NC?

For Fda jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Fda jobs in Raleigh, NC look for?

The top searched job categories for Fda jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Fda jobs?

Cities near Raleigh, NC with the most Fda job openings:

Fda jobs near you
Infographic showing various Fda job openings in Raleigh, NC as of August 2026, with employment types broken down into 92% Full Time, and 8% Contract. Highlights an 92% In-person, and 8% Remote job distribution, with an average salary of $79,108 per year, or $38 per hour.

FDA IND-IDE Specialist

UNC-Chapel Hill

Chapel Hill, NC • On-site

$30/hr

Part-time

Posted 6 days ago

University Of North Carolina At Chapel Hill rating

7.5

Company rating: 7.5 out of 10

Based on 48 frontline employees who took The Breakroom Quiz

316th of 630 rated colleges and universities

Job description

Posting Information
Department Research Compliance Services - 620200 Career Area Research Professionals Posting Open Date 08/31/2026 Application Deadline 09/03/2026 Position Type Temporary Staff (SHRA) Position Title FDA IND-IDE Specialist Position Number 20078418 Vacancy ID S028020 Full-time/Part-time Part-Time Temporary Hours per week 16 Work Schedule Position Location North Carolina, US Hiring Range $30.00 per hour Proposed Start Date 10/01/2026 Estimated Duration of Appointment 1 to 6 months
Position Information
Be a Tar Heel!
A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.
One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.
University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks that include numerous retail and restaurant discounts, savings on local child care centers and special rates for performing arts events.
Primary Purpose of Organizational Unit
Research Compliance Services (RCS) supports the Office of the Vice Chancellor for Research (OVCR). RCS enables and protects UNC-Chapel Hill`s $1 billion research enterprise by ensuring adherence to applicable regulations, policies, and ethical standards. In alignment with the OVCR`s mission to grow and support research through strategic leadership, infrastructure development, and external engagement, our unit provides essential oversight and guidance to facilitate compliant research practices. By working collaboratively with researchers and administrative units, we help mitigate risk, promote integrity, and uphold the standards necessary to advance the University`s varied and interdisciplinary research portfolio.
Position Summary
The temporary FDA IND/IDE Specialist is responsible for the organization, coordination, review, and submission of regulatory documents supporting Investigational New Drug (IND) applications, Investigational Device Exemption (IDE) applications, amendments, supplements, annual reports, and related FDA communications. This role ensures compliance with applicable FDA regulations, Good Clinical Practice (GCP), and other regulatory requirements governing clinical research involving drugs, biologics, and medical devices.
The specialist collaborates with the Clinical Trials Quality Assurance team and may interact with clinical research teams to ensure regulatory documents within regulatory submissions meet all submission requirements.
This position is important to the department's goal of increasing the audits we complete as well as continuing to provide excellent customer service. Because audits are generally scheduled and FDA submissions are not, it is challenging to manage the often-competing deadlines. Hiring a Temporary position to assist with FDA submissions will allow the auditors to better focus on audit completion. This increases our customer satisfaction as it allows us to complete audits in a timely manner. Additionally, hiring a Temporary position allows the department to make the best use of its resources because this will allow the higher paid auditors to focus on audit specific work.
  • IND Responsibilities:
    • Organize, compile, review, and submit IND applications, amendments, safety reports, annual reports, and FDA correspondence.
    • Coordinate cross-functional contributions for Chemistry, Manufacturing, and Controls (CMC), nonclinical, clinical, and investigator information sections.
    • Ensure IND submissions comply with FDA regulations, guidance documents, and eCTD requirements.
    • Track submission timelines and FDA review milestones.
    • Support responses to FDA information requests, clinical holds, and deficiency letters.
    • Maintain regulatory submission archives and documentation.
  • IDE Responsibilities:
    • Organize and submit IDE applications, supplements, amendments, progress reports, and device-related FDA communications.
    • Perform a cursory review of device development documentation, risk analyses, and clinical investigation plans.
    • Coordinate with the clinical research teams to support IDE submissions.
    • Ensure compliance with FDA device regulations and investigational device requirements.
    • Monitor IDE approvals, modifications, and post-approval obligations.
  • Regulatory Compliance:
    • Interpret FDA regulations and guidance documents relevant to clinical investigations.
    • Ensure compliance with:
      • 21 CFR Part 312 (Investigational New Drug Applications)
      • 21 CFR Part 812 (Investigational Device Exemptions)
      • 21 CFR Parts 50, 54, and 56
      • ICH-GCP Guidelines
      • Applicable FDA electronic submission requirements
    • Support inspection readiness activities and regulatory audits.
    • Maintain accurate records of regulatory submissions and approvals.
    • Provide submission status updates to project leadership.
Minimum Education and Experience Requirements
Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Management Preferences
* Coursework in Life Sciences, Regulatory Affairs, Biomedical Engineering, Pharmacy, Nursing, Public Health, or related field 
* Demonstrated experience conducting clinical research studies including IND or IDE submission knowledge
* Knowledge of FDA regulations governing clinical research or product development
* Strong technical writing and document management skills
* Excellent organizational or project management abilities
Special Physical/Mental Requirements Campus Security Authority Responsibilities

Not Applicable.

Special Instructions Quick Link https://unc.peopleadmin.com/postings/324707 Temporary Employment Policies
Temporary Employment Policies
Posting Contact Information
Office of Human Resources Contact Information
If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to employment@unc.edu
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.
Equal Opportunity Employer Statement
The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.

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About University of North Carolina at Chapel Hill

Sourced by ZipRecruiter

The University of North Carolina at Chapel Hill (UNC-Chapel Hill), located in Chapel Hill, NC, US, is renowned for being one of the leading research institutes in the world. Operating within the education industry, this public research university offers a broad range of undergraduate, graduate, and professional programs across various disciplines. UNC-Chapel Hill was chartered in 1789 and has maintained its legacy of academic excellence and innovative research for more than two centuries. The institution operates under the core values of excellence, innovation, engagement, accessibility, diversity, and inclusivity. Their mission is to serve the people of North Carolina and the United States by teaching a diverse community of students to become the next generation of leaders.

Industry

Colleges, universities, and professional schools

Company size

10,000+ Employees

Headquarters location

Chapel Hill, NC, US

Year founded

1789

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