Regulatory Affairs Support

Systems Plus, Inc.; Frederick (MD); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Systems Plus, Inc. in Frederick, MD is seeking a Regulatory Affairs Support to help advance regulated medical products from development to deployment.

You will collaborate with scientists, clinicians, and product teams to manage regulatory submissions, FDA interactions, and compliance for drugs, biologics, medical devices, and related solutions. The role requires a bachelor’s degree and at least four years of regulatory experience, with solid knowledge of regulatory pathways, submission types

Qualifications

• Minimum four (4) years of relevant experience required.
• 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.

Responsibilities

• Help bring breakthrough medical technologies to the Warfighter by supporting regulatory pathways that move products from development to deployment.
• Work with scientists, clinicians, and product-development teams to support regulatory submissions, FDA interactions, and compliance activities for drugs, biologics, medical devices, and other medical solutions.
• Coordinate regulatory documentation, stakeholder inputs, quality reviews, version control, and submission-readiness activities.
• Support regulatory-agency meetings and communications by preparing materials, documenting minutes, tracking questions and commitments, and assisting with responses.
• Assist with regulatory gap analyses and document compliance gaps, risks, dependencies, and recommended actions.
• Review and summarize clinical protocols, investigator brochures, progress reports, safety information, and preclinical and clinical documentation.
• Maintain current regulatory files, submission histories, correspondence, decision records, trackers, and regulatory-intelligence resources.
• Participate in cross-functional IPT activities and communicate regulatory status, deadlines, risks, and action items to product managers and stakeholders.
• Support Integrated Master Plans and Schedules for regulatory and clinical activities, including deliverables, meetings, dependencies, milestones, and estimated timelines.

Skills

4+ years regulatory experience

Regulatory submission knowledge

FDA regulations knowledge

Life sciences background

Strong analytical skills

Team collaboration

Education

Bachelor’s degree in a relevant area

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 Support

Position Type

Full-Time, Hybrid

Position Location

Frederick, Maryland

Tracking Code

01239

Daily Responsibilities

Help bring breakthrough medical technologies to the Warfighter by supporting the regulatory pathways that move innovative products from development to deployment. In this role, you will work closely with scientists, clinicians, and product-development teams to support regulatory submissions, FDA interactions, and compliance activities for drugs, biologics, medical devices, and other advanced medical solutions. This is an exciting opportunity to contribute to cutting-edge military medical programs while building expertise at the intersection of science, regulation, and product development.

• Support regulatory strategies and lifecycle activities for drugs, biologics, blood products, medical devices, and other military-relevant medical solutions.
• Research and summarize applicable FDA regulations, guidance, policies, and industry standards and identify potential impacts on developmental programs.
• Assist in preparing, reviewing, formatting, and maintaining regulatory submissions, including INDs, NDAs, PMAs, 510(k)s, Technical Files, and Clinical Evaluation Reports.
• Coordinate regulatory documentation, stakeholder inputs, quality reviews, version control, and submission-readiness activities.
• Support regulatory-agency meetings and communications by preparing materials, documenting minutes, tracking questions and commitments, and assisting with responses.
• Assist with regulatory gap analyses and document compliance gaps, risks, dependencies, and recommended actions.
• Review and summarize clinical protocols, investigator brochures, progress reports, safety information, and preclinical and clinical documentation.
• Maintain current regulatory files, submission histories, correspondence, decision records, trackers, and regulatory-intelligence resources.
• Participate in cross-functional IPT activities and communicate regulatory status, deadlines, risks, and action items to product managers and stakeholders.
• Support Integrated Master Plans and Schedules for regulatory and clinical activities, including deliverables, meetings, dependencies, milestones, and estimated timelines.

Degree and Certifications:

• Bachelor’s degree in a relevant area preferred

Required Experience:

• Minimum four (4) 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!