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Fda Jobs in Raleigh, NC (NOW HIRING)

Osv_bioventus

Regulatory Affairs Manager

Durham, NC · On-site

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Bioventus

Regulatory Affairs Manager

Durham, NC · On-site

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Diverse Lynx

SAS Viya developer

Raleigh, NC · On-site

Develop and optimize automated submission pipelines for FDA and global regulatory authorities * Ensure compliance with GxP, 21 CFR Part 11, HIPAA, and ICH E6 guidelines Data Engineering & Automation

tbc

Phlebotomy Trainer

Raleigh, NC · On-site

Training is performed in accordance to departmental procedures, processes, policies along with FDA and AABB regulations/standards and training records are maintained in a method that ensures ...

The Blood Connection

Phlebotomy Trainer

Raleigh, NC · On-site

Training is performed in accordance to departmental procedures, processes, policies along with FDA and AABB regulations/standards and training records are maintained in a method that ensures ...

Spectrum Staffing Services

Be Seen First

Quality Engineer

Raleigh, NC · On-site

$43 - $45/hr

Support, maintain, and improve the Quality Management System (QMS) in compliance with FDA, ISO 13485, MDSAP, and other applicable regulatory standards. * Develop, review, and maintain quality ...

Actalent

Clinical Nurse Educator

Cary, NC

$38.50 - $52.50/hr

This role focuses on counseling patients on FDA-mandated REMS medications, promoting therapy adherence, and ensuring safe and effective use of specialty drugs. The nurse educator collaborates closely ...

Actalent

Clinical Nurse Educator

Cary, NC

$38.50 - $52.50/hr

This role focuses on counseling patients on FDA-mandated REMS medications, promoting therapy adherence, and ensuring safe and effective use of specialty drugs. The nurse educator collaborates closely ...

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All JobsFda JobsFda Jobs in Raleigh, NC

Fda information

See Raleigh, NC salary details

$13

$38

$74

How much do fda jobs pay per hour?

As of Jul 7, 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.

Is it hard to get hired by the FDA?

Getting hired by the FDA can be competitive due to the specialized nature of the roles and the high standards for education, experience, and security clearances. Candidates often need relevant degrees, such as in science or public health, and may undergo rigorous screening and interviews. Strong technical skills and knowledge of regulatory processes improve chances of employment.

How much do you make working for FDA?

Salaries for FDA employees vary by position, experience, and location, but the average annual salary ranges from approximately $50,000 for entry-level roles to over $150,000 for senior scientists and management positions. Federal pay scales and certifications can influence compensation, and many roles include benefits such as health insurance and retirement plans.

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 are the key skills and qualifications needed to thrive as an FDA (U.S. Food and Drug Administration) 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 does an FDA (Food and Drug Administration) 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.

Does FDA have remote jobs?

The FDA offers some remote job opportunities, particularly in roles related to policy, research, and administrative support. However, many positions require on-site presence at FDA facilities or laboratories, and remote work availability depends on the specific role and department. Candidates should review individual job postings for remote work options and requirements.

What is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, which can have salaries exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and often involve overseeing regulatory policies and organizational management.

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 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 July 2026, with employment types broken down into 66% Full Time, 22% Part Time, 6% Temporary, and 6% Nights. Highlights an 78% In-person, 6% Hybrid, and 16% Remote job distribution, with an average salary of $79,108 per year, or $38 per hour.

Regulatory Affairs Manager

Osv_bioventus

Durham, NC • On-site

Full-time

Posted 3 days ago

Job description

Are you ready to work for a more active world?

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies to plan, prepare, and obtain approvals and compliance with national and international regulatory requirements (e.g. U.S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory expertise. The position will ensure that company policies, procedures and practices follow appropriate regulatory requirements.

Key Responsibilities:
1. Prepare, provide direction and oversee documentation packages for submission to global regulatory authorities to register new and/or maintain global approvals/clearances for assigned products.

2. Develop and maintain outstanding relationships with all regulatory and compliance agencies. Provide appropriate interface with global regulatory agencies in a variety of pre- and post-market forums. Provide guidance, interpretation, and opinions on complex regulatory matters (particularly related to submission pathways), outlining the different outcomes.
3. Prepares, collects, reviews, and assembles technical documentation required for writing regulatory and clinically-related submissions such as US 510K, PMAs, IDEs, NDAs, INDs, or international dossiers for new and modified products.
4. Liaises with project teams to develop regulatory strategies, testing requirements and other documentation to ensure regulatory data requirements are met..
6. Works with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products.

7. Monitor proposed and current global regulations and standards; assess impact of changes to such on assigned biologics product lines

8. Maintains awareness of global regulatory legislation and assesses its impact of development and manufacturing initiatives.

9. Evaluates design, manufacturing and labeling changes to ensure compliance with FDA, international, and other applicable governmental regulations.

10. Identifies and facilitates in the remedy of inefficiencies in Quality systems and processes.

11. Contribute to the Regulatory and/or Quality perspective on due diligence activities to identify issues related to the targeted product's development and/or its manufacture.

12. Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.

13. All other duties or projects as assigned.


Education and Experience (Knowledge, Skills & Abilities)

  • Bachelor's degree required (study area in Engineering or life sciences preferred, but other degrees may be considered)

  • Knowledge & experience working with biologics

  • Extensive knowledge of FDA and applicable international regulations required.

  • Working knowledge of US Quality Systems Regulations (QSRs) and/or Good Manufacturing Practices (GMPs), along with ISO 13485.

  • Minimum of 5 - 7 years of Regulatory and Quality regulations experience and submission experience required. Class II medical device experience required, Class III medical device and/or PMA / BLA/NDA submissions experience desired.

  • Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing

  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive

  • Being detail-oriented while having the ability to handle multiple projects/tasks

  • Experience interacting with US FDA is required

Are you the top talent we are looking for?

Apply now! Hit the "Apply" button to send us your resume and cover letter.

Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms ofdiversity andtake pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation.All individuals, regardless of personal characteristics, are encouraged to apply.

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