Our Mission: At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed.
We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations.
Position Summary
This individual will own end-to-end program leadership of New Product Development projects across R&D, Regulatory, Clinical, Quality, Manufacturing, and Commercial functions — ensuring disciplined execution, regulatory alignment, proactive risk mitigation, and on-time delivery to FDA submission and commercialization.
The ideal candidate is a high-impact, strategic executor with strong experience in medical device or combination product development and FDA approval pathways (PMA, 510(k), and/or PAS). This person thrives in complex regulatory environments, anticipates risk before it materializes, and drives cross-functional accountability without compromising innovation speed.
Essential Duties and Responsibilities
End to End Program Leadership for R&D Development Projects
Own the integrated master development plan from concept through FDA approval and launch of the product
Develop and maintain cross-functional program timelines with clear critical path identification and risk management
Drive accountability across R&D, Regulatory, Clinical, Quality, Manufacturing, and Commercial
Ensure program alignment to design control requirements and regulatory requirements.
Lead and coordinate cross functional program meetings
Regulatory and FDA Execution
Partner with Regulatory and Quality to align development strategy with the regulatory pathway and ensure program supports FDA expectations.
Ensuring support and for planning meetings with FDA and submission milestones
Anticipate and support planning for documentation, labeling, and testing risks before submission
Cross Functional Integration
Support and ensure proper translation of commercial and clinical requirements into executable development plans and timelines
Coordinate validation testing and integrate Quality, Risk Management, and Verification and Validation documentation into timeline
Risk and Issue Management
Proactively identify technical, regulatory, and operational risks
Lead formal risk review and mitigation strategies
Escalate critical issues with proposed solutions
Maintain decision logs and cross-functional alignment documentation
Executive and Leadership Communication
Provide clear, structured updates to executive leadership and C-suite.
Translate complex technical and regulatory challenges into executive level summaries
Support cross functional leaders with schedule management, resource management, and regular updates
Ensure transparency without alarmism
Required
Bachelor’s degree in a discipline related to job, engineering preferred.
5 - 10 years’ experience medical device or combination product development
Demonstrated success leading programs through FDA approval (PMA, 510(k), PAS, etc.)
Deep knowledge of FDA design controls, Risk Management, Software development lifecycle processes
Experience leading programs with cross-functional teams in highly regulated environments
Strong executive communication skills
Strong organizational and problem-solving skills.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Acute attention to detail
Proven ability to handle multiple projects and meet deadlines.
Strong knowledge of Program Management software – including Microsoft Office (Excel, PowerPoint, etc.) and Microsoft Project
Ability to travel up to 25% of the week, primarily domestic.
Preferred Qualifications
Experience with agile and waterfall delivery environments.
Experience with respiratory, ventilator, or critical care devices
Experience managing external partners, consultants, and / or test labs!
PMP certification
Competencies
Strong judgment, accountability, and self-management
Adaptive, forward-thinking leadership
Builds trust and credibility across teams
Strategic and analytical thinker
Executes with discipline and attention to detail
Effective collaborator and hands-on lead
Supervisory Responsibilities
N/A
Physical Demands and Work Environment
