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Fda Project Jobs (NOW HIRING)

E Logic

Project Manager

Silver Spring, MD · On-site

$85K/yr

E-logic is seeking a veteran Project Manager (PM) to lead a mission-critical federal contract supporting the Food and Drug Administration (FDA). In this role, you will serve as Key Personnel ...

Airgas

$71K/yr

R10095760 FDA Compliance Specialist (Open) Location: Independence, OH - Rockside Woods Blvd - ... Additional duties and projects as may be assigned. Are you a MATCH? Required Qualifications: * High ...

New

Danone

QFS Director

Mount Crawford, VA · On-site

$150K - $200K/yr

Ensure compliance with FDA, PMO, FSSC/GFSI and customer requirements * Drive quality culture and continuous improvement initiatives * Lead audit readiness and certification programs * Partner with ...

Stereotaxis

Project Manager

Minneapolis, MN

Ensure all projects comply with FDA, ISO 13485, and other relevant medical device industry regulations and standards. Identify potential project risks and develop mitigation strategies. Conduct ...

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Fda Project information

What is an FDA project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What are the key skills and qualifications needed to thrive as an FDA project manager?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What qualifications do you need to work for the FDA?

To work as an FDA project professional, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or health sciences. Advanced positions may require a master's degree or higher, along with relevant experience, knowledge of regulatory guidelines, and strong analytical skills. Certifications like Regulatory Affairs Certification (RAC) can also enhance qualifications.

What cities are hiring for Fda Project jobs?

Cities with the most Fda Project job openings:

What states have the most Fda Project jobs?

States with the most job openings for Fda Project jobs include:

Fda Project jobs near you
Infographic showing various Fda Project job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 7% Part Time, and 5% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution.

Surgical Oncologist - FDA

Tunnell Government Services

Bethesda, MD • On-site

Other

Re-posted 11 days ago

Job description

Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.
FDA CDRH - Medical Officer (Surgical Oncologist) SME Position Description
The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices.In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH's projects.
Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in surgical oncology, as relevant to medical devices.
Requirements and Qualifications

  • The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
  • In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
  • At least ten (10) years of relevant clinical experience
  • Certification from a U.S. relevant specialty board organization, e.g., the American Board of Surgery (ABS), Society of Surgical Oncology (SSO), etc.
  • Thorough understanding of current clinical practices in surgical oncology, including diagnosis and treatment, and current/emerging trends in practice.
  • Expert in function and utilization of medical devices commonly used as part of surgical oncology (e.g., advanced energy and resection devices [electrosurgical units, ultrasonic scalpels, argon beam coagulators], minimally invasive and robotic platforms [robotic-assisted surgery systems, laparoscopes and thoracoscopes], localization and navigation devices [tumor localization seeds, intraoperative ultrasound], tumor ablation systems [radiofrequency ablation and microwave ablation, cryoablation systems, irreversible electroporation], lymph node mapping systems [gamma probes, near-infrared fluorescence imaging], intraoperative therapy devices [hyperthermic intraperitoneal chemotherapy pumps, intraoperative radiation therapy systems]).
  • Familiarity with relevant FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 878 - General and Plastic Surgery Devices), and guidances is preferred.
  • Ability to communicate well with others using excellent written and verbal communication skills.
  • Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.

This position is 100% telework.
Must be a US Citizen or a Full Green Card holder.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

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