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JeffreyM Consulting

Laser Safety Specialist

Redmond, WA · On-site

$80 - $85/hr

Knowledge of FDA/CDRH laser product performance requirements, IEC 60825-1, and IEC 62471. * Experience calculating maximum permissible exposure (MPE), nominal ocular hazard distance (NOHD), and ...

JeffreyM Consulting

Laser Safety Specialist

Redmond, WA · On-site

$80 - $85/hr

Knowledge of FDA/CDRH laser product performance requirements, IEC 60825-1, and IEC 62471. * Experience calculating maximum permissible exposure (MPE), nominal ocular hazard distance (NOHD), and ...

JeffreyM Consulting

Laser Safety Specialist

Redmond, WA · On-site

$80 - $85/hr

Knowledge of FDA/CDRH laser product performance requirements, IEC 60825-1, and IEC 62471. * Experience calculating maximum permissible exposure (MPE), nominal ocular hazard distance (NOHD), and ...

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How much do fda cdrh jobs pay per hour?

As of Sep 14, 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 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 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 are the key skills and qualifications needed to thrive as an FDA CDRH 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 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 September 2026, with employment types broken down into 43% Full Time, and 57% Contract. Highlights an 71% In-person, and 29% Remote job distribution, with an average salary of $81,843 per year, or $39.3 per hour.

Sr. Regulatory Affairs Analyst - Medical Devices

Bethesda, MD • On-site

Tunnell Government Services
See more jobs at Tunnell Government Servicesexternal

Full-time

Re-posted 2 days ago

Job description

Sr. Regulatory Affairs SME - Medical Devices

Background: A Regulatory Affairs Analyst/subject matter expert is needed to provide contracted staffing support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. The mission of BARDA is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases (EID). Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. For more information on BARDA please visit their website at:  https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx and specifically the Division of Regulatory and Quality Affairs:  https://medicalcountermeasures.gov/barda/rqa

Duties of the position: This position will serve as regulatory affairs subject matter expert for multiple BARDA programs and projects involving development and manufacturing of in vitro diagnostic and device medical countermeasures specific to influenza, emerging infectious disease, CBRN threats (e.g. anthrax, filovirus, burn/blast trauma assessment, etc.), sepsis, and digital health technologies. These are products which are regulated by FDA's Center for Devices and Radiological Health (CDRH) and/or combination products crossing multiple centers. This technical advisory support covers the entire range from the inception of requirements to placing FDA cleared or approved products into the Strategic National Stockpile. Specific duties may include but are not limited to:

  • Provide regulatory affairs expertise and guidance for assigned programs and projects
  • Monitor 21CFR compliance on assigned programs and projects
  • Support BARDA in the review of contract-related documents, including regulatory strategy, development plans, study reports, study protocols and progress reports
  • Review and provide feedback on contractor FDA submissions, which may include IDEs, Pre-submissions (Q-subs), Premarket Submissions (510(k)), Premarket Applications (PMA), CLIA waivers etc.
  • Assist in preparation for contractor submission meetings with FDA, as assigned.
  • Attend contractor submission meetings with FDA and interpret FDA feedback as appropriate
  • Monitor BARDA supported contractors' project timelines for key regulatory and quality performance measures, and provide recommendations to overcome challenges and reduce program risk
  • Participate in site visits/audits to review and monitor vendor progress toward completion of contract milestones
  • Assist Project Team and BARDA supported contractors to develop and manage strategy, protocols and FDA applications for Emergency Use Authorizations
  • Participate or act as regulatory representative on various cross-functional teams, as assigned
  • Maintain current knowledge of the US competitive landscape, regulatory environment, regulations and guidance
  • Provide regulatory opinions on specific issues
  • Support contract initiation/negotiation efforts by providing regulatory and quality assessments of white papers and proposals to BARDA
  • Provide regulatory expertise on draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals
  • Draft meeting minutes, trip reports, and technical assessments and recommendations (including regulatory opinions) on the regulatory aspects of BARDA-contractor interactions

Education:

  • M.S. or higher in life sciences or related field is highly preferred

Desired Experience:

  • Minimum 15 years of device development; Government or industry experience in regulatory and/or quality affairs for diagnostic devices, particularly seeking expertise with imaging devices, software as a medical device, in vitro diagnostic devices, wearable technologies, digital health, and home use diagnostics.
  • Experienced in addressing FDA/CDRH hurdles (especially during late stage product development)
  • Experience in identifying and resolving quality, regulatory, clinical or process development problems for medical devices
  • Excellent people and communication skills, with a team-oriented leadership style

Must be US Citizen or Full Green Card holder.

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