Address
Form of workCEO – Medical Device Startup
Location: USA only
Citizen or Green Card Holders only
Salary $250k to $300K plus equity
Our client is a USA startup that has developed a revolutionary way of treating illnesses and injuries that can help individuals bypass surgical procedures or limit the level of surgical intervention required. They have done animal testing with excellent results.
They seek an initiative-taking and talented Chief Executive Officer (CEO) who has been through the full experience of taking Medical Devices from drawings/concept through FDA approval process, including Testing, Design Control Documentation, Clinical trials, manufacturing, Regulatory compliance and Commercialization, several times.
Must haves to be considered:
- Prior experience in both major companies and start-ups of Medical Devices
- 5 fives of end-to-end product development, clinical trial design and regulatory experience
- Involved in startups that have had successful exit events, acquisitions or IPO
- Experience with de novo and/or PMA FDA submissions:
- Obtaining reimbursement for a de novo or PMA device
- Including Design control process
- Clinical trial device manufacturing
- Device logistics and technical support for clinical trails
- Management of device complaints in clinical trials
- Operational input into clinical trial design
- Involvement in FDA submission
- 4 plus years managing operations for commercial launch of Medical Device
- Experience in managing CMO’s for Medical Devices, including transfer and qualification of manufacturing from one CMO to another
- Prior experience in the design and conduct of clinical trials
- Planning and managing the commercial launch of a Medical Device
- Strategic and operational planning
- Financial planning and budgeting
- Fund raising
- Organizational development including Medical Advisory Board
- Corporate governance
- History of recruiting a dedicated team to ensure above items are handled effectively
- Ability to manage conflict for a positive outcome
- Willing and able to travel oversea as needed, and hold meetings in evening hours with manufacturing facilities
- Master’s or Ph.D. with an undergraduate degree in Engineering, Physics, Biology, or similar degree desired
- A plus is speaking Mandarin or experience working with Taiwan manufacturers
Qualified candidates are welcome to send their resume, LinkedIn profile included, to Karen@Peopleconnectstaffing.com
