Are you passionate about steering complex technical projects from ideation to market success? We are seeking a dynamic and strategic Program Manager to lead cross-functional teams through the full product development lifecycle. This onsite position is based in Omaha, Nebraska, and relocation assistance is available for the right candidate. The ideal individual brings a strong background in regulatory affairs—particularly within biotech or medical device industries—and excels at driving alignment, innovation, and operational excellence across diverse teams and programs.

Position Overview

As a key leader, the Program Manager will oversee highly technical, cross-functional teams working across new product development and enhancement initiatives. This role requires strong expertise in regulatory frameworks, especially those relevant to FDA-regulated environments, and the ability to manage multiple projects within a broader portfolio. The Program Manager is expected to manage resources, timelines, budgets, and cross-departmental coordination—all from our Omaha, NE office.

Key Responsibilities

• Align project management deliverables with corporate goals, fostering continuous improvement across assigned portfolios.
• Lead programs using a Phase Gate product development process, ensuring compliance with ISO, GMP, FDA, and other applicable regulatory standards.
• Serve as the central point of coordination for all project stakeholders across R&D, Regulatory, Quality, Product Management, and Operations.
• Use project management tools to maintain clear communication, track milestones, and deliver regular status reports to the Director of Integrated Portfolio Management.
• Leverage new and adaptive approaches to accelerate timelines and achieve measurable outcomes.
• Ensure all programs align with established design control frameworks and comply with necessary regulatory documentation and processes.
• Proactively identify and mitigate risk, troubleshoot development challenges, and coordinate resolution activities.
• Manage cross-program synergies to optimize efficiency and consistency.
• Ensure all documentation—such as project plans, protocols, and compliance records—is accurate, complete, and audit-ready.
• Effectively communicate strategies, updates, and decisions with stakeholders at all organizational levels.
• Maintain current knowledge of regulatory trends and program management best practices, particularly in the medical device and biotech sectors.

Qualifications

• Bachelor’s degree in business, life sciences, engineering, or a related field with focus on program management.
• 5–7 years of experience managing complex projects; experience in medical device or biotech regulatory environments is strongly preferred.
• Demonstrated ability to lead diverse teams and influence without authority.
• Proficient in managing regulatory pathways and requirements throughout the product lifecycle.
• Strong organizational and analytical skills with a proactive, solution-driven mindset.
• PMP certification or equivalent preferred.

Core Competencies

• Accountability: Takes initiative, meets commitments, and ensures ownership of results.
• Customer Focus: Anticipates and responds to both internal and external client needs.
• Professionalism: Maintains integrity, ethics, and a positive approach in all interactions.
• Quality Orientation: Strives for excellence and continuous improvement.
• Team Focus: Collaborates effectively and fosters a culture of learning and support.

Technical Skills

• Experience conducting market and regulatory research to guide product development strategies.
• Strong critical thinking and decision-making capabilities informed by regulatory risk and market insights.
• Exceptional communication skills with a collaborative, team-oriented approach.
• Ability to prioritize competing feedback and fast-track regulatory or technical corrections.