Regulatory Engagement & FDA Liaison

Regulatory Engagement Specialist
Blu Omega is seeking a Regulatory Engagement Specialist to support our client by serving as a key liaison to the FDA. In this role, you will help the program managers navigate regulatory pathways, coordinate, and build strong working relationships with FDA stakeholders to advance high-impact health innovations.

Responsibilities
Build and maintain relationships with FDA points of contact

Collaborate with program managers and FDA contacts to support program development and ongoing program activities

Collaborate with additional teams to ensure PMs are supported with regulatory consultants

Assist IGA Specialists with identification of key programs and key points of contact within USG agencies/programs in relation to the program’s mission

Capture data into Intergovernmental tracking system

Create and maintain a dashboard of interagency engagements and programs

Draft reports on engagement or on potential opportunities as required

Create presentations tailored to agency/divisions, support outreach and scheduling with agency contacts as required

Qualifications
3+ years at FDA required

Experience with contracts research, management tracking tools

Must be detailed, diplomatic, with excellent communication, research, and writing skills, and flexible to juggle various projects at once

Advanced skills in PowerPoint, Excel, etc., and other related presentation and tracking software tools

Salary Range
$130K – $140K

Our final salary offer will be based on several factors, including depth of technical skills, work experience, education, certifications, and clearance.

What Blu Omega Can Offer You
Competitive benefits including Health Insurance, 401K w/ match, Paid Time Off and more.

Results driven culture that embraces our core values

Rewarding work contributing to our Nation’s mission critical programs

About Blu Omega
Blu Omega is a Woman Owned Small Business Federal Technology services firm headquartered in Washington DC and supporting clients nationally. We provide Technology solutions for enterprise and government customers. Our team has a past performance in a diverse range of programs including those for Data Management, Cloud/Infrastructure, Software Development and Enterprise Applications.

Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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