Senior Technical Advisor: DoD Medical Devices & Regulatory

Systems Plus, Inc.; Frederick (MD); Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Competitive benefits

Bonus/award programs

Global opportunities

Résumé du poste

Systems Plus in Frederick, MD, is seeking a Technical Advisor Support to join a DoD-focused program. You will advise product teams on clinical and regulatory strategies, review data, and help shape FDA and DoD regulatory pathways for next-gen medical devices, drugs, and biologics.

You will collaborate with cross-functional teams in a high-tempo environment, coordinate regulatory activities, and support outcomes from development through potential publication in peer-reviewed venues.

Qualifications

• Minimum 10 years of relevant experience in medical product development.
• Experience in regulatory strategy and FDA/DoD regulations.
• Background in clinical trials and pharmacovigilance.
• Ability to work in IPT meetings and cross-functional teams.

Responsabilités

• Advise product teams on clinical and regulatory strategies.
• Evaluate technical and safety data and provide expert recommendations.
• Coordinate regulatory strategy with DoD, FDA and DHA regulations.
• Prepare results for publication in peer-reviewed journals.

Connaissances

Regulatory affairs

Clinical research

Medical product development

DoD policies

Formation

Medical degree

Advanced degree or certification in medical/scientific field

Description du poste

Systems Plus in Frederick, MD, is seeking a Technical Advisor Support to join a DoD-focused program. You will advise product teams on clinical and regulatory strategies, review data, and help shape FDA and DoD regulatory pathways for next-gen medical devices, drugs, and biologics.

You will collaborate with cross-functional teams in a high-tempo environment, coordinate regulatory activities, and support outcomes from development through potential publication in peer-reviewed venues.