Are you a Regulatory Affairs professional seeking a Project Manager opportunity with an innovative and growing Medical Device consulting firm? If you consider yourself to be a Project Manager with excellent experience in Medical Device Project Management and Regulatory Affairs – WE WANT TO MEET YOU

Ventura Solutions is a trusted medical device and pharmaceutical staffing, consulting, and training firm. We believe that the best way to advance healthcare is through innovation and continuous improvement. We value our commitment to solving healthcare's toughest problems and delivering world-class products, services, and human resource solutions.

Our company offers an energized, collaborative, optimistic, and fun culture that cultivates an inventive spirit while being committed to exceeding client expectations. We offer tremendous opportunities for career growth, fulfilling projects, excellent salaries, competitive benefits, flexible hours, along with many work-from-home/remote opportunities. For more information about us, visit us at www.ventura-solutions.com.

While working in this role, you will have the ability to:

• Be a critical member of the Regulatory Affairs team by successfully managing projects of various scopes and aiding in the implementation of project management best practices.
• Identify the project's goals, objectives, and scope, and create a project plan that integrates the deliverables, work breakdown structure inputs and outputs, tasks, timelines, and resources required.
• Communicate with the project team and stakeholders, manage risks and issues, and monitor the budget and progress to ensure projects stay on track.

Responsibilities

• Ensure projects of varying scope are executed on time and within budget.
• Ensure project adherence to the client's Program Management Organization & Quality Management System (QMS).
• Lead cross-functional projects from inception to manufacturing transfer through production.
• Lead in the implementation of Project Management best practices and process improvement initiatives.
• Develop & maintain project plans, estimates, schedules, and budgets.
• Document & actively manage project requirements, including project scope definition and stakeholder alignment/approval.
• Provide project updates to various levels of the organization.
• Drive project reviews and regular project meetings.
• Manage meeting minutes, proactively manage actions and issues.
• Ensure open and clear communication within the project team & with project stakeholders.
• Serve as a moderator to resolve issues within the team.
• Act as liaison between the technical team and project stakeholders by understanding and communicating technical-business trade-offs.
• Actively manage any external parties involved with the project.
• Complete & ensure accurate project reports are completed.
• Manage project issues and risks.
• Aid in training of new personnel, where required.
• Perform other duties as assigned.

Qualifications

• Technical Bachelor's degree in Engineering or relevant work experience.
• Minimum five years of experience managing projects of various scope.
• PMP Certification (preferred but not required).
• Experience in regulatory affairs, including 510(k) submission (both domestic and international).
• Experience with digital health, AI, mechanical system software, X-ray, CT, Class II, and Class III devices.
• Experience with PMA Class III and international regulatory submissions.
• Detail-oriented & highly organized with well-developed time-management skills and processes for managing priorities.
• Experience with medical electronic equipment with wireless communication.
• Knowledge of Good Manufacturing Processes.
• Knowledge of Medical Device standards and requirements, such as V&V, IQ/OQ/PQ, Sterilization Validation, Biocompatibility, etc.
• Proven understanding of how to deliver compliant projects.
• A strong interest in the field of medicine, technology, and innovation.
• Proficiency in MS Office, Project, and Visio.
• Experience working with teams spread across multiple locations and time zones.
• Excellent written and verbal communication skills.
• Ability to take instruction and work as part of a corporate multidisciplinary team.
• Ability to travel as required to support project work.

Location

• Remote

Employee Type

• W2 Employee
• Open to 1099 engagements

Benefits

• Choice of medical dental and vision plans
• Paid Vacation Time
• Competitive base salary
• 401(k)

This is a great opportunity and we're looking to fill this role with the right person. If you are ready to embark on an amazing new career opportunity, APPLY RIGHT NOW

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled