Regulatory Affairs Support – WEMT

Goldbelt, Inc.; Frederick (MD); On-site; USD 95,000 - 125,000; Full time

Job summary

Goldbelt Apex is seeking a Regulatory Affairs Support to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role involves preparing INDs/NDAs/PMAs/510(k)s, technical files, and clinical evaluation reports while supporting FDA interactions.

The candidate will conduct regulatory gap analyses and advise product managers on regulatory risk and lifecycle strategy, contributing to program success across the medical product portfolio.

Qualifications

• Understanding of regulatory requirements across the medical product lifecycle.
• Knowledge of drugs, biologics, blood/blood products, medical devices.
• Ability to analyze regulatory pathways and propose compliant strategies.

Responsibilities

• Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
• Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports.
• Support FDA/regulatory agency interactions.
• Conduct regulatory gap analyses.
• Advise product managers and IPTs on regulatory risk and product lifecycle strategy.

Skills

FDA regulatory affairs

Medical product lifecycle

Drugs/biologics/medical devices

Regulatory submissions

Clinical/preclinical development

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 a Regulatory Affairs Support – WEMT.

Responsibilities

Essential Job Functions:

• Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
• Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports.
• Support FDA/regulatory agency interactions.
• Conduct regulatory gap analyses.
• Advise product managers and IPTs on regulatory risk and product lifecycle strategy.

Qualifications

Necessary Skills and Knowledge:

• FDA regulatory affairs.
• Medical product development lifecycle.
• Drugs, biologics and/or medical devices.
• Regulatory submissions.
• Clinical/preclinical development.

Minimum Qualifications:

• In-depth understanding of regulatory requirements throughout the medical product lifecycle.
• Strong understanding of drugs, biologics, blood/blood products, medical devices and/or related medical solutions.
• Strong analytical and problem-solving ability.
• Ability to work independently and collaboratively.
• Travel: Up to 20%

Preferred Qualifications:

• Current WEMT Regulatory Affairs incumbent.
• Direct IND/NDA/PMA/510(k) experience.
• FDA meeting/submission experience.
• DoD/DHA medical product experience.
• RAC or comparable regulatory credential.

Pay and Benefits

The annual salary for this position is $95,000 to $125,000.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy 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.