FDA-Regulated Health IT Program Director

Precise Software Solutions, Inc.; Rockville (MD); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health benefits

FSA/HSA

Retirement plan with 4% match

PTO 15 days

Disability insurance

Life and AD&D Insurance

Training and development

Wellness & discounts

Referral program

Charity donation match

Awards and recognition

Job summary

Precise Software Solutions, Inc. is seeking a Program Director to lead large federal health IT programs with a strong focus on FDA-regulated initiatives.

The role demands strategic leadership, deep engineering depth, and the ability to build high-performing, cross-functional teams and trusted client relationships. The ideal candidate has extensive FDA-regulated program experience, a solid engineering foundation, PMP certification, and a track record of delivering multimillion-dollar portfolios

Qualifications

• 15+ years of progressive IT program/project management experience, including 8+ years leading large teams.
• Extensive experience in FDA-regulated environments.
• Proven success in leading organizational change and system modernization.
• Track record of winning federal contracts.
• Experience leading Federal Health IT programs with multi-million-dollar budgets.
• Strong engineering foundation in software, systems, biomedical, or related field.
• Expertise in Agile, quality control, and continuous improvement.
• Exceptional interpersonal, negotiation, and communication skills.
• Ability to foster innovation, collaboration, and excellence across teams.
• Deep understanding of regulatory technology, compliance, and federal acquisition processes.
• PMP certification is required.
• Bachelor’s degree in engineering or related field.

Responsibilities

• Lead planning, execution, and delivery of large-scale federal health IT programs (FDA-regulated).
• Provide technical and management leadership across major project tasks.
• Develop and execute federal business development strategies.
• Present complex technical concepts to senior stakeholders.
• Manage competing priorities and maintain milestone alignment.
• Drive capture efforts for organic growth and re-bid contracts.
• Direct and mentor large cross-functional teams.
• Serve as liaison between business, technical teams, and federal clients.
• Oversee financials, resources, staffing, and vendor coordination.
• Build relationships with FDA and other federal health agencies.
• Identify and mitigate risks; champion continuous improvement.

Skills

Leadership

Agile methodologies

Communication

Negotiation

Innovation

Regulatory knowledge

Project management

Financial acumen

Change management

Collaboration

Risk management

Education

Bachelor’s degree in engineering or related field

PMP certification

Job description

Precise Software Solutions, Inc. is seeking a Program Director to lead large federal health IT programs with a strong focus on FDA-regulated initiatives.

The role demands strategic leadership, deep engineering depth, and the ability to build high-performing, cross-functional teams and trusted client relationships. The ideal candidate has extensive FDA-regulated program experience, a solid engineering foundation, PMP certification, and a track record of delivering multimillion-dollar portfolios