Regulatory Affairs Support – WEMT

Goldbelt Apex LLC; Frederick (MD); Presencial; USD 95.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision insurance

401(k) with company matching

Paid time off

Professional development opportunities

Descripción de la vacante

Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role includes preparing regulatory submissions and supporting interactions with regulatory agencies.

The position requires deep knowledge of the medical product lifecycle, strong analytical skills, and the ability to work independently and collaboratively. Travel up to 20% may be required.

Formación

• FDA regulatory affairs knowledge across drugs, biologics, and medical devices.
• Experience with regulatory submissions (INDs, NDAs, PMAs, 510(k)s).
• Strong analytical and problem-solving abilities.

Responsabilidades

• Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
• Prepare and 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 lifecycle strategy.

Conocimientos

FDA regulatory affairs

Medical product lifecycle

Drugs/biologics/devices

Regulatory submissions

Clinical/preclinical development

Analytical skills

Descripción del empleo

Overview

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

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.
• Strong analytical and problem-solving ability.
• Ability to work independently and collaboratively.

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.
• 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.