About the Position: MRDC is now part of the Defense Health Agency (DHA) Research & Development (R&D). We are themedical materiel developer, with responsibility for medical research, development and acquisition. Ourexpertise in these critical areas helps establish and maintain the capabilities the military needs to remainready and lethal on the battlefield. Please visit our website https://mrdc.health.mil/
This is a Direct Hire Solicitation
Summary
About the Position: MRDC is now part of the Defense Health Agency (DHA) Research & Development (R&D). We are themedical materiel developer, with responsibility for medical research, development and acquisition. Ourexpertise in these critical areas helps establish and maintain the capabilities the military needs to remainready and lethal on the battlefield. Please visit our website https://mrdc.health.mil/
Develop and implement comprehensive regulatory affairs strategies for advanced 'tech base' medical devices and diagnostic products to ensure mission-critical compliance from early development
Establish and maintain Quality Management Systems specifically tailored for the lifecycle of advanced medical diagnostics and early-stage technological innovations
Lead Medical Devices branch personnel, providing professional mentorship while managing high-priority project portfolios to meet operational milestones
Direct all Food and Drug Administration-regulated activities across the development pipeline, ensuring organizational adherence to federal statutes and agency mandates
Oversee the execution of nonclinical and clinical studies, ensuring all research activities strictly adhere to Good Clinical Practices and internal protocols
Manage manufacturing and testing operations to ensure full compliance with Good Manufacturing Practices and Quality Management System Regulations
Align product development plans with both pre-market and post-market Food Drug Administration requirements to facilitate efficient device clearance, approval, and long-term surveillance
Execute medical device classification processes and conduct risk assessments to categorize Significant Risk and Non-significant Risk research studies
Lead the preparation and strategic management of regulatory submissions, including Investigational Device Exemptions, premarket notifications, Deovo and Premarket approval
Perform expert regulatory reviews of complex Food and Drug Administration submissions, including Pre-Submissions, Premarket Approvals, and Emergency Use Authorization requests
Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.
This position requires the incumbent be able to obtain and maintain a determination of eligibility for a Secret security clearance or access for the duration of employment.
This position has a Temporary Duty (TDY) or business travel requirement of 15% of the time.
Appointment to this position is subject to a three-year probationary period unless the appointee has previously met the requirements as described in 5 CFR Part 315.
Qualifications
Who May Apply: US Citizens
DHA Research & Development (R&D) is participating in an alternative personnel system known as the Personnel Demonstration Project (PDP). The DB-03 payband is equivalent to the GS-13 step 1 to GS-14 step 10 level. In keeping with the Demonstration pay fixing policies, employees earning a salary that falls within this payband equivalent, may not receive an immediate pay increase (promotion) if appointed to this position. Future pay increases within the payband will be accomplished through the pay for performance management system.
In order to qualify, you must meet the education and experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document.
Basic Requirement for Regulatory Affairs Scientist (Devices):
Degree: Bachelor's or graduate (or higher level) degree with major study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of the position. This degree must be from an educational program accredited by an accrediting body recognized by the U.S.Department of Education at the time the degree was obtained.
You MUST submit copies of your transcripts supporting your education.
In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below:
Specialized Experience: One year of specialized experience which includes:
1. Experience interacting with varied groups and types of internal and external stakeholders to provide regulatory support across Food and Drug Administration (FDA) regulated research and development efforts.
2. Experience providing regulatory affairs guidance for medical research programs which develop medical device products.
3. Experience studying, interpreting, implementing, and/or providing regulatory guidance on relevant local, national, and/or international medical research regulations
4. Experience complying with Food and Drug Administration (FDA) regulations and guidelines including conducting quality reviews of FDA submissions for product approval
This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service (DB-02 / GS-12).
Regulatory Affairs Certification in Medical Devices is Desired (Not Required)
Education
FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.
Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted.
Additional information
Male applicants born after December 31, 1959 must complete a Pre-Employment Certification Statement for Selective Service Registration.
You will be required to provide proof of U.S. Citizenship.
This position requires a 3 year probationary period during which the agency evaluates your fitness and whether your continued employment advances the public interest. In making this determination, the agency may consider your performance and conduct; agency needs and interests; whether your continued employment supports organizational or Government goals; and whether it promotes the efficiency of the Federal service. Continued employment requires written certification that it advances the public interest.
Direct Deposit of Pay is required.
Selection is subject to restrictions resulting from Department of Defense referral system for displaced employees.
Recruitment or relocation incentives MAY be authorized for highly qualified candidates.
Multiple positions may be filled from this announcement.
Salary includes applicable locality pay or Local Market Supplement.
If you have retired from federal service and you are interested in employment as a reemployed annuitant, see the information in the Reemployed Annuitant information sheet.
Payment of Permanent Change of Station (PCS) costs is not authorized, based on a determination that a PCS move is not in the Government interest.
Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How you will be evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Once the announcement has closed, a review of your application package (resume, supporting documents, and responses to the questionnaire) will be used to determine whether you meet the qualification requirements listed on this announcement. Please follow all instructions carefully when applying, errors or omissions may affect your eligibility.
If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position.
Veterans and Military Spouses will be considered along with all other candidates.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
The documents you are required to submit vary based on whether or not you are eligible for preference in federal employment. A complete description of preference categories and the associated required documents is in the Applicant Checklist for Public Announcements.
As described above, your complete application includes your resume, your responses to the online questionnaire, and documents which prove your eligibility to apply. If you fail to provide these documents, you will be marked as having an incomplete application package and you will not be considered any further.
1. Your resume:
Your resume must be two pages or less and must support the specialized experience described in this announcement. Resumes exceeding two pages will be removed from consideration.
For each relevant work experience, make sure you include the employer's name, job title, start and end dates (include month and year), for qualifications purposes, the number of hours worked per week, and a brief description that show you can perform the tasks at the required level listed in the job announcement. If your resume does not contain this information, your application may be marked as incomplete, and you may not receive consideration for this position.
Use plain language. Avoid using acronyms and terms that are not easily understood. The hiring agency will not make assumptions about what's in your resume.
If your resume includes a photograph or other inappropriate material or content, it will not be used to make eligibility and qualification determinations, and you may not be considered for this vacancy.
This position has an individual occupational requirement and/or allows for substitution of education for experience. If you meet this requirement based on education you MUST submit a copy of your transcript with your application package or you will be rated ineligible. See: Transcripts and Licenses.
NOTE: Documents submitted as part of the application package, to include supplemental documents, may be shared beyond the Human Resources Office. Some supplemental documents such as military orders and marriage certificates may contain personal information for someone other than you. You may sanitize these documents to remove another person's personal information before you submit your application. You may be asked to provide an un-sanitized version of the documents if you are selected to confirm your eligibility.
If you are relying on your education to meet qualification requirements:
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
To apply for this position, you must complete the online questionnaire and submit the documentation specified in the Required Documents section below.
The complete application package must be submitted by 11:59 PM (EST) on 06/18/2026to receive consideration.
To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply. If you do not have a USAJOBS account, you will need to create one before beginning the application (https://apply.usastaffing.gov/ViewQuestionnaire/12981681).
Follow the prompts to select your resume and/or other supporting documents to be included with your application package. As a reminder, your resume must be two pages or less and must support the specialized experience described in this announcement. Resumes exceeding two pages will be removed from consideration. For additional information, refer to the 'Required Documents' section.
You will have the opportunity to upload additional documents to include in your application before it is submitted. Your uploaded documents may take several hours to clear the virus scan process.
After acknowledging you have reviewed your application package, complete the Include Personal Information section as you deem appropriate and click to continue with the application process.
You will be taken to the online application which you must complete in order to apply for the position. Complete the online application, verify the required documentation is included with your application package, and submit the application. Your resume selected in USAJOBS will be included, but you must re-select other documents from your USAJOBS account or your application may be incomplete.
It is your responsibility to verify that your application package (resume, supporting documents, and responses to the questionnaire) is complete, accurate, and submitted by the closing date. Uploaded documents may take up to one hour to clear the virus scan.
Additional information on how to complete the online application process and submit your online application may be found on the USA Staffing Applicant Resource Center.
KF-DD60RA DHA HQs - R/D ACT-MRDC
DO NOT MAIL
Fort Detrick, MD 21702
US
Next steps
If you provided an email address, you will receive an email message acknowledging receipt of your application. Your application package will be used to determine your eligibility, qualifications, and quality ranking for this position. If you are determined to be ineligible or not qualified, your application will receive no further consideration.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
The documents you are required to submit vary based on whether or not you are eligible for preference in federal employment. A complete description of preference categories and the associated required documents is in the Applicant Checklist for Public Announcements.
As described above, your complete application includes your resume, your responses to the online questionnaire, and documents which prove your eligibility to apply. If you fail to provide these documents, you will be marked as having an incomplete application package and you will not be considered any further.
1. Your resume:
Your resume must be two pages or less and must support the specialized experience described in this announcement. Resumes exceeding two pages will be removed from consideration.
For each relevant work experience, make sure you include the employer's name, job title, start and end dates (include month and year), for qualifications purposes, the number of hours worked per week, and a brief description that show you can perform the tasks at the required level listed in the job announcement. If your resume does not contain this information, your application may be marked as incomplete, and you may not receive consideration for this position.
Use plain language. Avoid using acronyms and terms that are not easily understood. The hiring agency will not make assumptions about what's in your resume.
If your resume includes a photograph or other inappropriate material or content, it will not be used to make eligibility and qualification determinations, and you may not be considered for this vacancy.
This position has an individual occupational requirement and/or allows for substitution of education for experience. If you meet this requirement based on education you MUST submit a copy of your transcript with your application package or you will be rated ineligible. See: Transcripts and Licenses.
NOTE: Documents submitted as part of the application package, to include supplemental documents, may be shared beyond the Human Resources Office. Some supplemental documents such as military orders and marriage certificates may contain personal information for someone other than you. You may sanitize these documents to remove another person's personal information before you submit your application. You may be asked to provide an un-sanitized version of the documents if you are selected to confirm your eligibility.
If you are relying on your education to meet qualification requirements:
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
To apply for this position, you must complete the online questionnaire and submit the documentation specified in the Required Documents section below.
The complete application package must be submitted by 11:59 PM (EST) on 06/18/2026to receive consideration.
To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply. If you do not have a USAJOBS account, you will need to create one before beginning the application (https://apply.usastaffing.gov/ViewQuestionnaire/12981681).
Follow the prompts to select your resume and/or other supporting documents to be included with your application package. As a reminder, your resume must be two pages or less and must support the specialized experience described in this announcement. Resumes exceeding two pages will be removed from consideration. For additional information, refer to the 'Required Documents' section.
You will have the opportunity to upload additional documents to include in your application before it is submitted. Your uploaded documents may take several hours to clear the virus scan process.
After acknowledging you have reviewed your application package, complete the Include Personal Information section as you deem appropriate and click to continue with the application process.
You will be taken to the online application which you must complete in order to apply for the position. Complete the online application, verify the required documentation is included with your application package, and submit the application. Your resume selected in USAJOBS will be included, but you must re-select other documents from your USAJOBS account or your application may be incomplete.
It is your responsibility to verify that your application package (resume, supporting documents, and responses to the questionnaire) is complete, accurate, and submitted by the closing date. Uploaded documents may take up to one hour to clear the virus scan.
Additional information on how to complete the online application process and submit your online application may be found on the USA Staffing Applicant Resource Center.
KF-DD60RA DHA HQs - R/D ACT-MRDC
DO NOT MAIL
Fort Detrick, MD 21702
US
Next steps
If you provided an email address, you will receive an email message acknowledging receipt of your application. Your application package will be used to determine your eligibility, qualifications, and quality ranking for this position. If you are determined to be ineligible or not qualified, your application will receive no further consideration.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
