Senior Blood SME — PM Strategy & Regulatory Support
Goldbelt, Inc.
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Benefits offered by this job
Job summary
Goldbelt Apex is seeking a Product Management Support Blood SME – WPAC to provide senior subject-matter expertise in blood products, transfusion medicine, and combat casualty care for healthcare technology projects.
The role involves advising product managers on advanced medical product development, reviewing regulatory documentation, and supporting regulatory strategies, CMC, testing, and training across IPTs.
Qualifications
- Subject-matter expertise in blood/blood products, blood research/operations, transfusion medicine.
- Ability to provide independent senior-level technical analysis and recommendations.
- Experience with combat casualty care and traumatic hemorrhage.
- Experience with FDA-regulated medical products.
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
Job description
Goldbelt Apex is seeking a Product Management Support Blood SME – WPAC to provide senior subject-matter expertise in blood products, transfusion medicine, and combat casualty care for healthcare technology projects.
The role involves advising product managers on advanced medical product development, reviewing regulatory documentation, and supporting regulatory strategies, CMC, testing, and training across IPTs.
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