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Fda Cdrh Jobs (NOW HIRING)

Axiom Talent Platform

OR

$309.75K/yr

Act as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information. * Advise on pre- and post-approval requirements (quality ...

Element Science

Director, Regulatory Affairs

Redwood City, CA · On-site

$183.70K - $242.40K/yr

FDA (CDRH), including experience navigating Q-Sub/Pre-Sub meetings, deficiency letter responses, and informal FDA interactions; Notified Body experience a plus. * Evidence of technical knowledge to ...

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How much do fda cdrh jobs pay per hour?

As of May 29, 2026, the average hourly pay for fda cdrh in the United States is $39.35, according to ZipRecruiter salary data. Most workers in this role earn between $24.52 and $49.04 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an FDA CDRH (Center for Devices and Radiological Health) professional, and why are they important?

To thrive as an FDA CDRH professional, you need a background in biomedical engineering, life sciences, or a related field, often with advanced degrees and experience in regulatory affairs. Familiarity with regulatory submission systems (like eSTAR, eCopy), FDA guidance documents, and certifications such as RAC (Regulatory Affairs Certification) are typically important. Strong analytical skills, attention to detail, and clear communication are essential for evaluating medical device safety and efficacy and collaborating across teams. These competencies ensure compliance, protect public health, and support the timely approval of safe and effective medical devices.

What types of cross-functional collaboration can I expect in an FDA CDRH role?

In an FDA Center for Devices and Radiological Health (CDRH) position, you'll frequently work with multidisciplinary teams, including scientists, engineers, medical officers, and regulatory specialists. Collaboration is essential for reviewing medical device submissions, conducting safety evaluations, and developing regulatory policies. You'll often participate in meetings, share findings, and contribute your expertise to ensure that devices meet federal safety and efficacy standards. This collaborative approach not only enriches your own knowledge but also ensures comprehensive oversight of medical devices.

What is the FDA CDRH?

The FDA CDRH stands for the Center for Devices and Radiological Health, which is a branch of the U.S. Food and Drug Administration. Its primary role is to ensure the safety and effectiveness of medical devices and radiation-emitting electronic products in the United States. The CDRH oversees the premarket approval process, monitors postmarket performance, and enforces regulations to protect public health. It also provides guidance to manufacturers, healthcare professionals, and consumers regarding medical devices and their safe use.

What is the difference between Fda Cdrh vs Fda Cdrh?

AspectFda Cdrh

Since the comparison is between the same job title, Fda Cdrh vs Fda Cdrh, there is no difference. Both roles involve regulatory oversight of medical devices, require similar certifications, and are employed within the FDA's Center for Devices and Radiological Health. The responsibilities, work environment, and industry usage are identical, making them essentially the same position.

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Fda Cdrh jobs near you
Infographic showing various Fda Cdrh job openings in the United States as of May 2026, with employment types broken down into 82% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 100% Hybrid job distribution, with an average salary of $81,843 per year, or $39.3 per hour.

Medical Officer - Plastic Surgeon

Tunnell Government Services

Bethesda, MD • On-site

Full-time

Posted 7 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 (Plastic Surgeon) 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 clinical medicine and plastic surgery, 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 Plastic Surgery (ABPS), etc.
  • Thorough understanding of current clinical practices in plastic surgery, including diagnosis and treatment, and current/emerging trends in practice.
  • Expert in function and utilization of medical devices commonly used as part of plastic surgery (e.g., aesthetic and body contouring devices [liposuction systems, energy-based skin tighteners, lasers], precision cutting and dissection tools (e.g., electrosurgical units, dermatomes, skin graft meshers), microsurgical equipment (operating microscopes, micro-instruments, doppler ultrasound), breast and implant-related tools (tissue expanders, keller funnel), craniofacial and bone tools (piezoelectric bone scalpels, internal fixation systems) to include specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems.
  • Familiarity with 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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