Regulatory Affairs Support – WEMT

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company matching

Tax-deferred savings options

Supplementary benefits

Paid time off

Professional development opportunities

Job summary

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 FDA and regulatory agencies.

The position emphasizes regulatory risk assessment, lifecycle planning, and collaboration with product managers and cross-functional teams. Travel up to 20% is required.

Qualifications

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

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

Product lifecycle

Drugs/biologics/devices

Regulatory submissions

Clinical/preclinical

Job description

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 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.

• medical, dental, and vision insurance
• a 401(k) plan with company matching
• tax-deferred savings options
• supplementary benefits
• paid time off
• professional development opportunities