Senior Product Manager, Defense Medical Devices (Hybrid)

Systems Plus, Inc.

Frederick (MD)

Hybrid

USD 110,000 - 150,000

Full time

6 days ago
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Job summary

Systems Plus, Inc. is seeking a Senior Product Management Support (FHP) in Frederick, Maryland.

The role focuses on driving development of next‑generation medical products and coordinating with DoD, clinical, regulatory, and industry stakeholders to advance programs from concept through deployment. You will support regulatory submissions, clinical protocols, and program documentation, working within an IPT framework and ensuring compliance with GCP, IND, and FDA requirements.

Qualifications

  • Minimum eight years of DoD acquisition and medical product development experience.
  • Experience with regulated healthcare products (drugs, biologics, devices).
  • Familiarity with FDA regulations, INDs, GCP, cGMP, and regulatory pathways.
  • Ability to prepare technical, regulatory, and executive-level docs.
  • Strong communication and stakeholder-engagement skills.

Responsibilities

  • Support development of next-gen medical products for Warfighter health.
  • Collaborate with military leaders, clinicians, researchers, and industry partners.
  • Assist IPTs, Working Groups, MDRs, and program-management activities.
  • Develop and maintain product-development documentation and briefings.
  • Coordinate with stakeholders to gather and present technical and regulatory info.
  • Support IND, FDA submissions, and regulatory compliance efforts.
  • Review technical/regulatory docs and provide recommendations to PMs.
  • Support training on GCP, investigational products, and regulatory pathways.
  • Maintain program records and ensure timely deliverables.

Skills

Communication skills
Organizational skills
Stakeholder engagement
Task-management
Microsoft Office 365

Education

Bachelor’s degree in a relevant area

Tools

Microsoft Office 365

Job description

Systems Plus, Inc. is seeking a Senior Product Management Support (FHP) in Frederick, Maryland.

The role focuses on driving development of next‑generation medical products and coordinating with DoD, clinical, regulatory, and industry stakeholders to advance programs from concept through deployment. You will support regulatory submissions, clinical protocols, and program documentation, working within an IPT framework and ensuring compliance with GCP, IND, and FDA requirements.

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