PeopleConnect Staffing is Hiring a COO Near Boston, MA
Description COO - Medical Device Startup Location: USA only Citizen or Green Card Holders only Salary $250k to $300K plus equity Our client 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 just closed their Series C round They seek an initiative-taking and talented Chief Operation Officer (COO) who has been through the full FDA approval process, including Testing, Design Control Documentation, Clinical trials, and understand Regulatory compliance. Qualifications and Experiences:
Prior experience in both major devices companies and start-ups with product development, clinical and regulatory experience
Experience with de novo and/or PMA FDA submissions:
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
8 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
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
A plus is speaking Mandarin
Qualified candidates are welcome to send their resume, LinkedIn profile included, to [email protected]