Regulatory Affairs Support – WEMT

Goldbelt, Inc.•Frederick, MD

1d•Remote

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 Support – WEMT. This position is contingent upon the successful award of a contract currently under bid.

Requirements

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

Nice To Haves

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.

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.