Regulatory Affairs Expert — Drug/Device (Hybrid)

Systems Plus, Inc.; Frederick (MD); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Systems Plus, Inc. is seeking a Regulatory Affairs Subject Matter Expert in Frederick, Maryland. This full-time, hybrid role focuses on directing regulatory strategy across drugs, biologics, medical devices and related medical solutions to support military and federal agency products.

You will develop submissions, interact with FDA and other agencies, mentor team members, and collaborate with R&D, manufacturing, and clinical teams to ensure regulatory compliance throughout the product lifecycle.

Qualifications

• Minimum eight (8) years of relevant regulatory experience.
• Strong understanding of the product development lifecycle and regulatory requirements.
• Experience with drugs, biologics, blood and blood products, medical devices, and related solutions.
• Ability to work independently and as part of a team.

Responsibilities

• Help accelerate development of lifesaving medical products by guiding regulatory strategy for drugs, biologics, devices and related solutions.
• Provide specialized regulatory guidance and serve as a technical resource on requirements, strategies, and processes.
• Develop and review regulatory strategies, including submissions and regulatory agency communication.
• Evaluate regulatory guidelines and assess impact on development programs.
• Prepare and review regulatory submissions (INDs, NDAs, PMAs, 510(k)s, etc.) and related documents.
• Support interactions with regulatory agencies, including meetings and sponsor communications.
• Conduct gap analyses of processes against current regulatory requirements.
• Provide training and mentorship on regulatory requirements and best practices.
• Stay current on changes to regulations and communicate impacts to the team.
• Collaborate with R&D, manufacturing, clinical, and marketing to ensure lifecycle regulatory compliance.
• Advise product managers and leadership on regulatory risks and opportunities.
• Review summaries, protocols, investigator brochures, and safety data for regulatory use.
• Coordinate and assist in development of Integrated Master Plan for FDA and non-FDA activities.

Skills

Regulatory strategy

FDA regulations

IND/NDAs/PMAs

Cross-functional teamwork

Regulatory submissions

Life sciences

Mentorship

Communication

Education

Bachelor's degree

Job description

Systems Plus, Inc. is seeking a Regulatory Affairs Subject Matter Expert in Frederick, Maryland. This full-time, hybrid role focuses on directing regulatory strategy across drugs, biologics, medical devices and related medical solutions to support military and federal agency products.

You will develop submissions, interact with FDA and other agencies, mentor team members, and collaborate with R&D, manufacturing, and clinical teams to ensure regulatory compliance throughout the product lifecycle.