Regulatory Affairs Scientist (Devices)

Duties

• 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

Requirements

Conditions of employment

• 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 .

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: .

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 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.