Medical Tech Advisor & Regulatory SME

Goldbelt, Inc.; Frederick (MD); On-site; USD 100,000 - 140,000; Full time

Job summary

Goldbelt Apex in Frederick, MD, seeks a Technical Advisor Support – WPAC to provide scientific and regulatory expertise for medical product development.

You will support clinical research strategy, review regulatory packages, and serve as SME on IPTs, delivering technical reviews and leadership briefings.

Travel up to 20% is expected; the salary range is $100,000–$140,000 yearly with a comprehensive benefits package.

Qualifications

• Medical degree or higher in a medical/scientific/technical field.
• DoD acquisition knowledge applied with clinical expertise.
• Travel up to 20%.

Responsibilities

• Provide scientific/medical/technical expertise supporting medical product development.
• Support clinical research strategy, planning and execution of trials.
• Review IND/IDE, regulatory submissions, clinical data, CMC and technical docs.
• Act as technical SME on IPTs and cross‑functional teams.
• Provide written reviews, briefings and recommendations to product managers and leadership.

Skills

Medical product development

Clinical research

FDA regulatory

Technical analysis

Technical writing

Education

Medical degree / doctorate

Job description

Goldbelt Apex in Frederick, MD, seeks a Technical Advisor Support – WPAC to provide scientific and regulatory expertise for medical product development.

You will support clinical research strategy, review regulatory packages, and serve as SME on IPTs, delivering technical reviews and leadership briefings.

Travel up to 20% is expected; the salary range is $100,000–$140,000 yearly with a comprehensive benefits package.