Regulatory Affairs Subject Matter Expert I

Knowesis Inc.; Frederick (MD); Hybrid; USD 95,000 - 125,000; Full time

Job summary

Knowesis is seeking a Regulatory Affairs Subject Matter Expert I to provide specialized regulatory guidance for FDA processes across drugs, biologics and devices, supporting military health system initiatives. This hybrid role requires the ability to obtain and maintain a DoD-tier clearance and deliver regulatory strategies, submissions, and lifecycle management.

You will develop regulatory plans, prepare submissions (INDs, NDAs, PMAs, 510(k)s), review guidelines, and mentor team members on best

Qualifications

• Bachelor's degree in a scientific, health, or regulatory field.
• At least 8 years of full-time work experience in regulatory affairs for medical products (drugs, biologics, or devices).
• Proven experience preparing and reviewing formal FDA submissions.

Responsibilities

• Provide expert advice and guidance on FDA regulations for military-relevant medical solutions.
• Develop and review regulatory strategies, submission planning, dossier preparation, and communications with regulatory agencies.
• Prepare and review regulatory submissions including INDs, NDAs, PMAs, and 510(k)s.
• Evaluate regulatory guidelines and policies for impact on development programs.
• Conduct gap analyses of processes against current regulatory requirements and mentor team members.

Skills

Regulatory affairs

FDA submissions

Regulatory strategy

Dossier preparation

Education

Bachelor's degree in a scientific/regulatory field

Job description

• Location Various,Fort Detrick, MD, 21702,United States
• Job Category Program & Policy Evaluation
• Employee Type FT Exempt
• Required Degree 4 Year Degree

Description

Position : Regulatory Affairs Subject Matter Expert I

Work Environment: Hybrid / Telework Eligible (Routine and situational telework is authorized .)

Clearance Required: TIER 1: Non-critical sensitive position (Must be able to obtain and maintain )

Anticipated Salary Range: $95,000 - $125,000

Knowesis is seeking a Regulatory Affairs Subject Matter Expert I to provide specialized regulatory guidance to ensure successful product development and lifecycle management for WPAC initiatives. This expert navigates complex FDA processes for drugs, biologics, and devices to bring acute care capabilities to the military health system.

The Job Duties and Responsibilities include but are not limited to the following:

• Provide expert advice and guidance on the application of FDA regulations to the development of military-relevant medical solutions.
• Develop and review regulatory strategies, submission planning, dossier preparation, and communication with regulatory agencies.
• Prepare and review regulatory submissions including INDs, NDAs, PMAs, and 510(k)s.
• Evaluate and interpret regulatory guidelines and policies to assess their impact on developmental programs.
• Conduct gap analyses of existing processes against current regulatory requirements and provide mentorship to team members on best practices.

Required Qualifications:

• Bachelor's Degree in a scientific, health, or regulatory field.
• At least 8 years of full-time work experience in regulatory affairs for medical products (drugs, biologics, or devices).
• Proven experience preparing and reviewing formal FDA submissions.

Preferred Qualifications:

• Regulatory Affairs Certification (RAC).
• Experience working with DoD-sponsored medical product development initiatives.

Knowesis is committed to providing equal employment opportunities to all individuals based on merit and qualifications. We prohibit discrimination in all aspects of employment as required by Title VII of the Civil Rights Act and other applicable federal laws. Our company values all applicants and employees and fosters a work environment where everyone is treated with respect and dignity.