Senior Blood Products Product Manager & SME

Goldbelt Apex LLC; 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

Job summary

Goldbelt Apex LLC in Frederick, MD is seeking a Product Management Support Blood SME for WPAC. You will serve as a senior SME in blood products, advise product managers on regulatory strategies, and support clinical and regulatory programs.

The role requires reviewing technical documentation, communicating risks to leadership, and collaborating across IPTs. Travel up to 30% is expected; salary ranges from $100,000 to $165,000 with a comprehensive benefits package including health, 401(k), and

Qualifications

• Subject-matter expertise in blood/blood products and transfusion medicine.
• Experience with combat casualty care and traumatic hemorrhage.
• Experience with medical product research/development and regulatory strategies.

Responsibilities

• Serve as senior SME in blood products, blood operations, and related fields.
• 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 LLC in Frederick, MD is seeking a Product Management Support Blood SME for WPAC. You will serve as a senior SME in blood products, advise product managers on regulatory strategies, and support clinical and regulatory programs.

The role requires reviewing technical documentation, communicating risks to leadership, and collaborating across IPTs. Travel up to 30% is expected; salary ranges from $100,000 to $165,000 with a comprehensive benefits package including health, 401(k), and