PeopleConnect Staffing is Hiring a Chief Executive Officer - Medical Device Near San Francisco, CA
Description CEO - 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 [email protected]