Job description
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CPT-8586 Project Manager / Virtual Assistant for Medical Device Startup
REQUIRED SERVICE: Telehealth Business Support
REQUESTED EXPERIENCE TIER LEVEL: Senior Support Level
MIN. HOURS/WEEK: 40 hours
SHIFT TIME ZONE: CST
SHIFT HOURS: Flexible but must follow US business hours
SHIFT DAYS: Monday-Friday
Number of VAs: 1
GENDER PREFERENCE: N/A
LANGUAGES SPOKEN/PREFERENCE: English
ACCENT PREFERENCE: Neutral
REGION PREFERENCES: N/A
We are looking for Administrative/Business Support VAs to work with us!
Experienced candidates are okay to apply.
We accept VAs who are looking for a full-time or part-time position.
We consider your preferred work schedule.
This is either for voice or non-voice positions.
We are a startup bringing an innovative syringe technology to market, with particular applications in the Botox industry. We’ve completed initial market research showing strong potential and are now entering the FDA approval phase. We’re seeking a detail-oriented Project Manager/VA to coordinate our FDA 510(k) submission process and support ongoing market research activities. This is a remote position working directly with the founder to ensure all regulatory requirements are met on schedule.
Primary 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
510(k) Testing Requirements to Coordinate
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
Additional Responsibilities During Downtime
- 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
Communication and Reporting
- 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
Tools and Technology 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
Requirements
- 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
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
Client industry: Healthcare
Want to work with this amazing client? Apply now and join 20four7VA! Join the remote world, today.
What we offer:
- Competitive rates
- Weekly payments
- Annual rate increase (based on performance)
- Paid time off
- Paid holidays
- Various open roles are available
- Free training and upskilling
- Constant support and guidance from managers and mentors
- Clear schedules and guidelines
- A vibrant community always ready to support you
- And more!
