Regulatory Affairs Subject Matter Expert

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

Got the Government Contractor Blues? Looking for a company that cares and goes beyond just filling another contract billet? Well, look no further! Experience this family-oriented company that takes pride in you and will help you grow where your passions lie. Holding many Defense & Federal government contracts around the globe, with Systems Plus, you have the opportunity to take on new and evolving challenges, aim beyond what you think you are capable of, and work in collaborative, dynamic, and high-tempo environments.

Our employees are our most valued asset, and we invest in our people because we are in it for the long term. We are committed to your success and well-being and offer competitive benefits packages, salaries, bonus/award programs, and a high potential for professional growth and job opportunities worldwide.

Systems Plus is the company for you! Experience the difference, and let’s talk about your future at Systems Plus today.

Position Title

Regulatory Affairs Subject Matter Expert

Position Type

Full-Time, Hybrid

Position Location

Frederick, Maryland

Tracking Code

01232

Daily Responsibilities

Help accelerate the development of lifesaving medical products for the Warfighter by serving as a regulatory expert at the forefront of military medical innovation. In this role, you will guide the regulatory strategy for drugs, biologics, medical devices, and other advanced medical solutions, working closely with scientists, clinicians, product managers, and government leaders. Your expertise will directly influence the successful development, approval, and fielding of critical capabilities that support military readiness and improve health outcomes.

• Provide specialized guidance and support and serve as a technical resource, offering in-depth expertise on relevant regulatory requirements, strategies, and processes to ensure successful product development, submission, and lifecycle management.
• Provide expert advice and guidance on drugs, biologics, and devices and their application to the development of military-relevant medical solutions.
• Develop and review regulatory strategies, including submission planning, dossier preparation, and communication with regulatory agencies.
• Evaluate and interpret regulatory guidelines, directives, and policies, and assess their impact on developmental programs.
• Prepare and review regulatory submissions, including but not limited to INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting submission packages and minutes, audit and inspection reports.
• Support regulatory agency interactions, including preparation for meetings, communication with Sponsors, responses to queries, and management of commitments.
• Conduct gap analyses of existing processes and documentation against current regulatory requirements.
• Provide training and mentorship to team members on regulatory requirements and best practices.
• Stay current on changes to relevant regulations, guidelines, and industry standards and communicate these changes to the team.
• Collaborate with cross-functional teams, including R&D, manufacturing, clinical, and marketing, to ensure regulatory compliance throughout the product lifecycle.
• Proactively communicate with and advise product managers, IPTs, and leadership on regulatory risks, opportunities, and issues.
• Collaborate as necessary to identify regulatory affairs strategies to optimize product development across the portfolio.
• Review and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data.
• Facilitate an understanding of requirements for compliance with all applicable FDA regulations.
• Understand and plan for future clinical trials and other pre-clinical trial milestones.
• Coordinate and assist in the review of all pre-clinical trial documents.
• Keep current files of all information disseminated by the FDA and other policy bodies that affect products and will interpret, synthesize, and incorporate the new information into the organization.
• Assist in the development of a comprehensive Integrated Master Plan/IMS of FDA and non-FDA regulatory and clinical activities (e.g. tasks, documents, meetings,) to include estimated timelines required to support the product development of medical devices, drugs, biologics, blood and blood products and or other medical solutions.

Degree and Certifications

• Bachelor’s degree in a relevant area preferred

Required Experience

• Minimum eight (8) years of relevant experience required
• Have a strong understanding of the product development lifecycle and regulatory requirements at each stage.
• In depth knowledge of development of drugs, biologics, blood and blood products, medical devices, and other medical solutions.
• Possess strong problem-solving and analytical skills.
• Be able to work independently and as part of a team.

Required Clearance

• Background investigation.

About Systems Plus

Systems Plus is headquartered in Rockville, MD with over 2 decades of experience providing Global Enterprise Management, Technology, Engineering and Professional services and solutions across Defense and Federal Civilian government sectors.

From Discovery to Delivery, Systems Plus brings a greater measure of confidence, commitment and value to our clients. With various Defense and Federal contracts across the United States, Europe and Pacific/Asia, we are driving innovation and excellence within the Special Operations Forces Components and Commands, Defense Health Agency, United States Air Force, United States Marine Corps, National Institute of Standards and Technology, House of Representatives and more.

Through our diverse portfolio of clients and capabilities we power vision and insight—discover what’s possible with a Small Business that thinks BIG!