Project Manager, Regulatory Compliance Specialist

About VERO Biotech 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 The role is a highly organized, execution-oriented Project Manager to support critical business initiatives, including New Product Development (NPD), Business infrastructure, manufacturing and Quality programs.

This role requires foundational experience in medical device development and is ideal for project managers that thrive in a fast-paced, cross-functional environment. The successful candidate will support planning, coordination, and documentation activities across R&D, Regulatory, Quality, Operations, and Commercial teams.

This individual will play a critical role in ensuring timelines, deliverables, and design control requirements are met while building strong cross-functional alignment.

Essential Duties and Responsibilities Program Execution and Coordination:

Support of multiple concurrent, critical programs across various phases

Maintain detailed project plans, Gantt charts, and milestone tracking tools

Track risks, action items, and dependencies across cross-functional teams

Prepare and distribute program dashboards and executive level updates

Strong communication skills and positive influence on the team quality and execution

Design Control and Regulatory Support Support adherence to FDA design control and change control requirements

Assist with maintenance of Design History Files Coordinate inputs for regulatory submissions

Track testing progress for V&V, human factors and usability testing, biocompatibility, etc.

Support traceability matrix updates and requirement tracking

Cross-Functional Alignment Coordinate across Engineering (hardware, software, systems), Clinical, Regulatory Affairs, Quality, Operations / Manufacturing, Supply Chain, Finance, and Commercial Escalate timeline risk and resource constraints early

Help ensure proper stakeholders are integrated into product development planning

Documentation and Process Maintain program documentation repositories

Assist in preparing leadership summaries and board level materials

Drive continuous improvement in program management

Collect data and provide routine reporting on operational metrics and key performance indicators.

Serves as a promoter of the program management processes and initiatives and assists company resources in the practice of these initiatives.

Other duties as assigned by the manager.

Bachelor’s degree in Engineering, Life Sciences, or related technical field2-5 years of experience in Medical Device development and technical project coordination

Basic understanding of FDA Design Controls, Verification and Validation processes, Change Control, and Risk Management Excellent written and oral 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 Microsoft Office (Excel, PowerPoint, etc.) as well as Project Management applications

Ability to travel up to 25%
Desired Qualifications

Experience with agile and waterfall delivery environments.

Experience supporting regulatory submission in combination products or respiratory/critical care devices.proven ability to work cross-functionally and act as a liaison between technical and business focused teamsPMP certification

Competencies

Execution discipline and follow-through

Systems thinking and prioritization

Clear communication and escalation

Cross-functional collaboration

Data-driven decision support

Accountability and ownership

Comfortable in a fast-paced environment handling multiple tasks and projects

Able to organize and manage large amounts of files, tasks, schedules, and information

Self-directed…