Senior Blood SME: Product Strategy & Regulatory Advisory

Goldbelt Apex, LLC; Frederick (MD); On-site; USD 100,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid time off

Job summary

Goldbelt Apex is seeking a Product Management Support Blood SME - WPAC to serve as senior subject-matter expert in blood products, transfusion medicine, and related operations. You will advise product managers on advanced medical product development and participate in regulatory strategies and testing.

This role includes reviewing technical documentation, collaborating on IPTs, and traveling up to 30% to support DoD acquisition lifecycle and fielding activities.

Qualifications

• Subject-matter expertise in blood/blood products, transfusion medicine and related operations.
• Ability to provide independent senior-level technical analysis and recommendations.
• Experience with FDA-regulated medical products and regulatory considerations.

Responsibilities

• Serve as senior SME in blood/blood products, blood research, blood operations, combat casualty care, traumatic hemorrhage, hematology and transfusion medicine.
• Advise product managers on advanced medical product development.
• Support clinical/nonclinical programs, regulatory strategies, CMC, testing, fielding and training.
• Review technical and regulatory documentation.
• Participate as senior SME on IPTs and communicate risks/recommendations to leadership.

Skills

Blood products

Transfusion medicine

Combat casualty care

Medical product development

Clinical studies

FDA-regulated products

Job description

Goldbelt Apex is seeking a Product Management Support Blood SME - WPAC to serve as senior subject-matter expert in blood products, transfusion medicine, and related operations. You will advise product managers on advanced medical product development and participate in regulatory strategies and testing.

This role includes reviewing technical documentation, collaborating on IPTs, and traveling up to 30% to support DoD acquisition lifecycle and fielding activities.