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Fda Internship Jobs (NOW HIRING)

Nova Biomedical

RA Intern

Waltham, MA

$25/hr

... FDA QSR, ISO 13485, and IVDD/IVDR. Prior coursework, internships, or early experience in Regulatory or Quality within IVD or medical devices is preferred. If you're passionate about Regulatory ...

Nova Biomedical

RA Intern

Waltham, MA · On-site

$25/hr

... FDA QSR, ISO 13485, and IVDD/IVDR. Prior coursework, internships, or early experience in Regulatory or Quality within IVD or medical devices is preferred. If you're passionate about Regulatory ...

FOOD FUSION NJ LLC

Quality Inspector

Bridgeton, NJ · On-site

$18 - $21/hr

Support internal SQF audits and FDA/USDA inspection readiness by organizing records and ensuring ... related field (internship or co-op experience counts) * Basic understanding of food safety ...

FOOD FUSION NJ LLC

Quality Inspector

Bridgeton, NJ · On-site

$18 - $21/hr

Support internal SQF audits and FDA/USDA inspection readiness by organizing records and ensuring ... related field (internship or co-op experience counts) * Basic understanding of food safety ...

FOOD FUSION NJ LLC

Quality Inspector

Bridgeton, NJ · On-site

$18 - $21/hr

Support internal SQF audits and FDA/USDA inspection readiness by organizing records and ensuring ... related field (internship or co-op experience counts) * Basic understanding of food safety ...

Actalent

Qa Associate

Centerbrook, CT

$31 - $36/hr

Internship or academic experience in QA, lab environments, or regulated industries is a plus ✅ ... Exposure to FDA regulations (21 CFR Part 111, 211, or 820) * Familiarity with QA processes like ...

Actalent

Qa Associate

Centerbrook, CT

$31 - $36/hr

Internship or academic experience in QA, lab environments, or regulated industries is a plus ✅ ... Exposure to FDA regulations (21 CFR Part 111, 211, or 820) * Familiarity with QA processes like ...

Stereotaxis

Manufacturing Engineer

Saint Louis, MO

$71K - $91K/yr

Experience in medical device or regulated industry (FDA, ISO 13485) Exposure to electromechanical ... internships or co-ops acceptable) Basic understanding of manufacturing processes and engineering ...

DermaSensor

Customer Success Intern

Miami, FL

Our flagship product, the FDA-cleared DermaSensor™ medical device, is a cost-effective handheld ... Duration Summer 2026 internship, with exact start and end dates to be determined based on candidate ...

Henry Schein One

Regulatory Affairs Specialist

Ames, IA · On-site +1

$60K - $80K/yr

... internships/co-ops acceptable) * Familiarity with US FDA pathways for SaMD (potential 510(k) or De Novo) and 21 CFR Part 820; exposure to 21 CFR Part 11 is a plus. * Familiarity with regulatory ...

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How much do fda internship jobs pay per hour?

As of Jun 16, 2026, the average hourly pay for fda internship in the United States is $15.54, according to ZipRecruiter salary data. Most workers in this role earn between $12.50 and $17.55 per hour, depending on experience, location, and employer.

Does the FDA offer internships?

Yes, the FDA offers internships for students and recent graduates through programs like the FDA Student Intern Program and the FDA Pathways Program. These internships provide hands-on experience in regulatory science, public health, and related fields, often requiring application through USAJOBS and adherence to specific eligibility criteria.

What is a FDA Internship job?

An FDA Internship is a temporary position designed for students or recent graduates to gain hands-on experience in regulatory science, public health, and policy. Interns work on projects related to drug approval, food safety, medical devices, and other areas overseen by the U.S. Food and Drug Administration. These internships provide valuable exposure to federal regulations, research, and compliance processes. Opportunities may be available in various FDA offices and centers, offering mentorship and professional development.

Is 22 too old for an internship?

The FDA internship program typically welcomes applicants of various ages, including those in their early twenties. Age is generally not a barrier as long as candidates meet the educational and qualification requirements, such as being enrolled in or recent graduates of relevant programs. Internships often focus on skills, motivation, and academic background rather than age alone.

What are the big 4 internships?

The 'Big 4' internships typically refer to internship programs offered by the four largest professional services firms: Deloitte, PricewaterhouseCoopers (PwC), Ernst & Young (EY), and KPMG. These internships provide experience in auditing, consulting, tax, and advisory services and are highly competitive for students pursuing careers in accounting and finance.

What kinds of projects or tasks do FDA interns typically work on during their internship?

FDA interns often work on a variety of projects related to public health, regulatory policy, scientific research, or data analysis, depending on their department. Interns may assist with laboratory studies, analyze clinical trial or adverse event data, contribute to policy reviews, or help draft scientific reports and communications. Supervision and mentorship are typically provided by experienced professionals, and interns often have opportunities to attend seminars or networking events. This hands-on experience provides valuable practical insight into the federal regulatory process and helps interns build skills for future careers in science or public health.

What are the key skills and qualifications needed to thrive in the Fda Internship position, and why are they important?

To thrive as an FDA Intern, you generally need a background in life sciences, public health, pharmacy, or a related field, along with strong analytical and research skills. Familiarity with data analysis tools, laboratory techniques, or regulatory databases is often beneficial depending on the specific internship focus. Excellent written and verbal communication, attention to detail, and the ability to work collaboratively in multidisciplinary teams are stand-out soft skills. These attributes are crucial for meeting the FDA's standards for study integrity, regulatory compliance, and effective information sharing within complex projects.

Is it hard to get a job at the FDA?

Getting an FDA internship can be competitive due to high demand and limited openings, often requiring strong academic performance, relevant coursework, and sometimes prior experience. Applicants should prepare a solid application, including transcripts and letters of recommendation, and demonstrate an interest in regulatory science or public health.
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Infographic showing various Fda Internship job openings in the United States as of June 2026, with employment types broken down into 4% Internship, 75% Full Time, 20% Part Time, and 1% Temporary. Highlights an 85% Physical, 1% Hybrid, and 14% Remote job distribution, with an average salary of $32,333 per year, or $15.5 per hour.
Senior Director, Regulatory Affairs REMS Program

Senior Director, Regulatory Affairs REMS Program

Cytokinetics

South San Francisco, CA • On-site

$263K - $307K/yr

Full-time

Posted 12 days ago

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Reporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is responsible for leading regulatory strategy and execution related to Risk Evaluation and Mitigation Strategy (REMS) and providing regulatory compliance oversight for REMS.
Responsibilities:
Strategic Leadership
  • Serve as regulatory lead and FDA point of contact for all REMS-related interactions, including original REMS submissions, assessments, modifications, and revisions
  • Lead development of REMS strategies that align with benefit-risk profile, labeling, post marketing commitments, and lifecycle plans. Drives cross-functional alignment and decision-making.
  • Prepare and lead REMS discussions for FDA meetings (Type A/B/C, Advisory Committees, inspections)
  • Manage all aspects of preparation and timely submission of REMS filings, REMS assessments, and responses to queries
  • Oversee implementation and evaluation of REMS in alignment with the broader program strategy
  • Monitor evolving FDA REMS guidance and proactively assess regulatory impact
  • Provide regulatory guidance to Commercial, Market Access, and Patient Services to ensure compliant execution.
  • Identify gaps that may pose regulatory risks and identify related solutions and mitigation plans
  • Develop and maintain internal regulatory processes, templates, and best practices
REMS Design & Governance
  • Own global oversight of REMS design, including Elements to Assure Safe Use (ETASU), communication plans, implementation systems, and assessment methodologies
  • Act as a key member of the REMS governance committee, leading compliance and assessment/reporting functions and partnering with operations to ensure end-to-end program oversight and regulatory compliance.
  • Ensure REMS requirements are clearly translated into operational execution plans.
Oversight & Compliance
  • Review and approve REMS related documentation, assessments, training materials, and vendor deliverables.
  • Oversee REMS metrics, compliance trends, and effectiveness assessments from a regulatory perspective.
  • Align with Quality to ensure inspection readiness, audit support, and CAPA management.
  • Support regulatory inspections and FDA audits related to REMS.
Management
  • May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs
  • Mentors department personnel and optimizes employee performance by developing employees and promoting career growth.
Qualifications:
  • 10+ years of relevant experience in the pharmaceutical/biotech industry, with strong expertise in REMS operations, strategy and compliance
  • Bachelor's degree is required, preferably in a scientific discipline; advanced degree (MD, PharmD, or PhD) is a plus
  • Excellent working knowledge of regulatory requirements and environment applicable to REMS, including an understanding of GXP
  • Direct experience leading or negotiating REMS with FDA strongly preferred
  • Ability to work effectively across teams, functions and with outside partners
  • Excellent oral and written communication skills
  • Excellent organizational and time management skills, attention to detail, and ability to independently drive deliverables to completion
  • Ability to work effectively in a fast-paced environment while managing multiple priorities
    #LI-HYBRID

Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $263,880 - $307,860 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
  • We do not conduct job interviews through non-standard text messaging applications
  • We will never request personal information such as banking details until after an official offer has been accepted and verified
  • We will never request that you purchase equipment or other items when interviewing or hiring
  • If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer

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