Regulatory Affairs Subject Matter Expert I

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

Benefits offered by this job

Health Insurance

Dental

Vision

STD/LTD

Life Insurance

401k Match

Voluntary Benefits

Job summary

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 role requires developing regulatory strategies, preparing submissions (INDs/NDAs/PMAs/510(k)s), and mentoring colleagues on best practices within a hybrid

Qualifications

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

Responsibilities

• Provide expert regulatory guidance on the application of FDA regulations to military-relevant medical solutions.
• Develop regulatory strategies, submission planning, dossiers, 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 for developmental programs.
• Conduct gap analyses of existing processes against current regulatory requirements and mentor team members.

Education

Bachelor's Degree in scientific/health/regulatory field

Regulatory Affairs Certification (RAC)

Job description

Brief Description

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.