Regulatory Affairs Subject Matter Expert I

Position: Regulatory Affairs Subject Matter Expert I

Location: Fort Detrick, MD

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)

Status: Contingent

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.

Benefits:

• Health (PPO & HDHP) Insurance, Dental, Vision, STD & LTD, Basic Life Insurance, 401k Company Match, & Voluntary Products.

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.