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 insurance

Dental insurance

Vision insurance

401(k) plan with company match

Paid time off

Professional development

Descripción de la vacante

Goldbelt Apex seeks a Regulatory Affairs Support - WEMT to guide regulatory strategies across drugs, biologics, blood products and medical devices, ensuring compliance throughout the product lifecycle.

You will prepare and review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports, and support FDA interactions and regulatory gap analyses.

Collaborate with product managers and IPTs to assess regulatory risk and shape lifecycle strategy while traveling up to 20%.

Formación

• 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%.

Responsabilidades

• 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.

Conocimientos

FDA regulatory affairs

Medical product lifecycle

Drugs biologics devices

Regulatory submissions

Clinical/preclinical development

Descripción del empleo

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.