Regulatory Affairs Subject Matter Experts – WPAC

Overview

Please note that this position is contingent upon the successful award of a contract currently under bid. Goldbelt Apex, part of the Healthcare Technology Transformation Group, is a data‑focused company dedicated to process and quality in every aspect. As experts in healthcare IT, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Responsibilities

• Serve as senior regulatory SME supporting military‑relevant drugs, biologics, blood products, medical devices, and other medical solutions.
• Develop and review regulatory strategies and submission plans.
• Prepare and review INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting packages, audit reports, and inspection products.
• Support interactions with FDA/regulatory agencies and sponsors.
• Advise product managers/IPTs on regulatory risks, opportunities, and lifecycle strategy.
• Mentor teams on regulatory requirements and best practices.

Qualifications

• Senior FDA regulatory affairs expertise.
• Experience with drugs, biologics, blood/blood products and/or medical devices.
• Understanding of the product development lifecycle.
• Proficiency in regulatory submissions and agency interactions.
• Knowledge of clinical and preclinical development.
• Cross‑functional collaboration with R&D, manufacturing, clinical, and product management teams.
• In‑depth knowledge of medical product development and applicable regulatory requirements.
• Strong regulatory strategy, analytical, problem‑solving, and communication skills.
• Ability to operate independently as a subject‑matter expert.
• Travel up to 20%.

Preferred Qualifications

• Current WPAC Regulatory Affairs incumbent(s) highest‑priority incumbent capture target.
• Direct experience preparing IND, NDA, PMA, and 510(k) submissions.
• FDA meeting and regulatory agency interaction experience.
• Blood/biologics/combat casualty care regulatory experience.
• DHA/DoD medical acquisition experience.
• RAC or comparable regulatory certification.

Pay and Benefits

The annual salary for this position is $100,000 to $150,000.

• Medical, dental, and vision insurance
• 401(k) plan with company matching
• Tax‑deferred savings options
• Supplementary benefits
• Paid time off
• Professional development opportunities