Regulatory Affairs Subject Matter Experts - WPAC

Goldbelt Apex, LLC; Frederick (MD); On-site; USD 100,000 - 150,000; Full time

Job summary

Goldbelt Apex, LLC, part of the Healthcare Technology Transformation Group, is seeking a Regulatory Affairs Subject Matter Expert for WPAC to lead regulatory strategies for military-relevant drugs, biologics, blood products and medical devices.

Responsibilities include developing and reviewing submission plans, preparing INDs/NDAs/PMAs/510(k)s, and reports; coordinating with FDA and sponsors; guiding teams on lifecycle strategy and regulatory requirements.

Qualifications

• 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.
• Experience with drugs, biologics, blood products and/or medical devices.
• Experience preparing IND/NDA/PMAs/510(k) submissions.
• DoD/DHA medical acquisition experience and RAC certification is a plus.

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.

Skills

Senior FDA regulatory affairs

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory compliance

Job description

Overview

Please note that this position is contingent upon the successful award of a contract currently under bid.

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.

Summary:

Goldbelt APEX is looking for aRegulatory Affairs Subject Matter Experts - WPAC.

Responsibilities

Essential Job Functions:

• 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.

Qualifications

Necessary Skills and Knowledge:

• 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.

Minimum Qualifications:

• 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.


• Travel: Up to 20%

Preferred Qualifications:

• 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.

Pay and Benefits

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

At Goldbelt, we value and reward our team's dedication and hard work. We provide a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.