Regulatory Submissions Specialist (Drugs/Devices/Biologics)

Systems Plus, Inc.; Frederick (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

Systems Plus, Inc. is seeking a Regulatory Affairs Specialist to support submissions and regulatory activities for drugs, biologics, blood products, medical devices, and related solutions. You will collaborate with scientists, clinicians, and product teams to ensure compliance and timely filings.

The role requires 4+ years of regulatory experience, deep knowledge of development lifecycles, and strong analytical and communication skills to navigate FDA requirements and cross-functional processes.

Qualifications

• Degree: Bachelor's degree in a relevant area preferred.
• Minimum four (4) years of relevant regulatory experience required.
• Strong understanding of product development lifecycle and regulatory requirements at each stage.
• In-depth knowledge of drugs, biologics, blood products, medical devices, and related solutions.
• Strong problem-solving and analytical skills.
• Ability to work independently and as part of a team.

Responsibilities

• Support regulatory strategies and lifecycle activities for drugs, biologics, blood products, medical devices, and military-relevant solutions.
• Research and summarize FDA regulations, guidance, policies, and industry standards; identify impacts on programs.
• Assist in preparing, reviewing, formatting, and maintaining regulatory submissions (INDs, NDAs, PMAs, 510(k)s, Technical Files, CREs).
• Coordinate regulatory documentation, inputs, quality reviews, version control, and submission readiness.
• Support agency meetings by preparing materials, documenting minutes, tracking questions, and assisting with responses.
• Assist with regulatory gap analyses, risks, dependencies, and recommended actions.
• Review clinical protocols, investigator brochures, progress reports, safety info, and documentation.
• Maintain current regulatory files, submission histories, correspondence, trackers, and intelligence resources.
• Participate in cross-functional IPT activities; communicate regulatory status, deadlines, risks, and actions.
• Support Integrated Master Plans and Schedules for regulatory and clinical activities.

Skills

Regulatory knowledge

Documentation management

Communication

Team collaboration

Analytical thinking

Education

Bachelor's degree in a relevant area

Job description

Systems Plus, Inc. is seeking a Regulatory Affairs Specialist to support submissions and regulatory activities for drugs, biologics, blood products, medical devices, and related solutions. You will collaborate with scientists, clinicians, and product teams to ensure compliance and timely filings.

The role requires 4+ years of regulatory experience, deep knowledge of development lifecycles, and strong analytical and communication skills to navigate FDA requirements and cross-functional processes.