Project Manager, Virtual Assistant

Summary

Join 20four7VA and work as a Project Manager/Virtual Assistant for a medical device startup developing innovative syringe technology. You will coordinate the FDA 510(k) submission process, manage testing facilities, and conduct market research. This remote position requires strong organizational skills, attention to detail, and experience with project management tools. You will work directly with the founder to ensure all regulatory requirements are met on schedule. This is a full-time position with flexible hours, requiring you to work during US business hours aligned with Central Time Zone (CST).

Requirements

• Proficiency with Google Workspace or Microsoft Office suite
• Experience with project management and tracking tools
• Ability to quickly learn new software platforms as needed
• Strong documentation skills for maintaining detailed records
• Exceptional organizational and documentation skills
• Strong attention to detail and follow-through
• Experience with project management tools and methodologies
• Excellent written and verbal English communication
• Ability to work independently and proactively identify potential issues
• Experience coordinating with multiple stakeholders
• Must work during US business hours aligned with Central Time Zone (CST)
• Comfortable with early morning hours in the Philippines to accommodate US time zone

Responsibilities

• Coordinate the production and distribution of 2,000 physical prototypes to testing facilities
• Track and manage relationships with multiple testing houses conducting sterilization validation and other required tests
• Create and maintain detailed documentation of all testing processes
• Serve as the liaison between testing facilities and our regulatory expert
• Ensure timely completion of all tests required for 510(k) submission
• During FDA review period: conduct market research, coordinate customer interviews, and gather competitive intelligence
• Manage project timelines and provide regular status updates
• Sterilization validation (ISO 11137 or ISO 11135)
• Biocompatibility testing (ISO 10993)
• Shelf-life and aging studies
• Performance testing: Needle penetration force
• Flow rate verification
• Dead space volume measurement
• Leak testing
• Seal integrity testing
• Human factors and usability studies (IEC 62366)
• Package integrity testing
• Transport/shipping validation
• Material compatibility studies
• Particulate matter testing (USP <788>)
• Pyrogen/endotoxin testing (USP <85>)
• Cytotoxicity testing
• Sterility assurance level (SAL) validation
• Conduct and analyze competitor research to identify market positioning opportunities
• Build and maintain a database of potential customers and distribution channels
• Research relevant industry conferences, events, and networking opportunities
• Create and organize a knowledge base of industry regulations and standards
• Monitor industry news and prepare weekly summaries of relevant developments
• Assist with preparation of investor materials and pitch decks
• Develop preliminary marketing materials and social media strategy for post-approval
• Research potential manufacturing partners and supply chain logistics
• Create standard operating procedures (SOPs) for future quality management system
• Support development of business plans and financial projections
• Assist with patent research and intellectual property monitoring
• Daily email check-ins with status updates
• Weekly video meetings to review progress and priorities
• HELP format for weekly reporting (Highlights, Emerging issues, Lowlights, Priorities)
• Regular action review of completed tasks and upcoming deliverables

Preferred Qualifications

• Previous experience in healthcare, medical devices, or regulatory environments
• Familiarity with FDA submission processes
• Background in market research or customer interviews
• Experience with CRM software and data analysis

Benefits

• Competitive rates
• Weekly payments
• Annual rate increase (based on performance)
• Paid time off
• Paid holidays
• Free training and upskilling
• Constant support and guidance from managers and mentors
• Clear schedules and guidelines
• A vibrant community always ready to support you