Regulatory Affairs Specialist I — FDA Submissions

Knowesis Inc.; Frederick (MD); On-site; 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

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