Senior Blood Product PM & Strategy SME

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Professional development

Job summary

Goldbelt Apex, part of the Healthcare Technology Transformation Group, is seeking a Product Management Support Blood SME – WPAC based in Frederick, MD. You will act as a senior SME across blood products, blood operations, and transfusion medicine, guiding product managers in advanced development and regulatory strategies.

You will support clinical and regulatory programs, review documentation, and participate on IPTs, communicating risks and recommendations to leadership.

Qualifications

• Subject-matter expertise in blood/blood products.
• Independent senior-level technical analysis & recommendations.
• Experience in transfusion medicine and/or combat casualty care.

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 research

Clinical studies

FDA-regulated products

Job description

Goldbelt Apex, part of the Healthcare Technology Transformation Group, is seeking a Product Management Support Blood SME – WPAC based in Frederick, MD. You will act as a senior SME across blood products, blood operations, and transfusion medicine, guiding product managers in advanced development and regulatory strategies.

You will support clinical and regulatory programs, review documentation, and participate on IPTs, communicating risks and recommendations to leadership.