Regulatory Affairs Subject Matter Experts – WPAC

Goldbelt, Inc. • Frederick, MD

4d

About The Position

Goldbelt Apex, a 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 experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices. Goldbelt APEX is looking for a Regulatory Affairs Subject Matter Experts – WPAC. This position is contingent upon the successful award of a contract currently under bid.

Requirements

• Senior FDA regulatory affairs expertise.
• Drugs, biologics, blood/blood products and/or medical devices.
• Product development lifecycle.
• Regulatory submissions and agency interactions.
• Clinical and preclinical development.
• Cross-functional work with R&D, manufacturing, clinical and product management.
• 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 an SME.

Nice To Haves

• Current WPAC Regulatory Affairs incumbent(s) highest-priority incumbent capture target.
• Direct experience preparing IND/NDA/PMA/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.

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/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.

Benefits

• medical, dental, and vision insurance
• a 401(k) plan with company matching
• tax-deferred savings options
• supplementary benefits
• paid time off
• professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed