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Executive Leader
2 months ago
Executive Leader - Medical Technology Innovator
Location: USA only
Citizen or Green Card Holders only
Salary $250k to $300K plus equity
PeopleConnect Staffing is representing a pioneering startup in the medical technology sector that has created an innovative approach to treating health conditions, enabling patients to avoid surgical interventions or reduce the extent of such procedures. Successful animal trials have demonstrated promising outcomes.
They are in search of a proactive and skilled Executive Leader who possesses comprehensive experience in guiding medical devices from initial concepts through the FDA approval pathway, encompassing Testing, Design Control Documentation, Clinical Trials, Manufacturing, Regulatory Compliance, and Commercialization, on multiple occasions.
Key Qualifications:
- Demonstrated history in both large corporations and startups within the medical device field.
- A minimum of five years of complete product development, clinical trial design, and regulatory expertise.
- Experience in startups that have achieved successful exits, acquisitions, or IPOs.
- Familiarity with de novo and/or PMA FDA submissions, including:
- Securing reimbursement for de novo or PMA devices.
- Involvement in the Design Control process.
- Clinical trial device manufacturing.
- Logistics and technical support for clinical trials.
- Management of device-related complaints during clinical trials.
- Operational contributions to clinical trial design.
- Participation in FDA submission processes.
- Over four years of experience managing operations for the commercial launch of medical devices.
- Proven track record in overseeing CMOs for medical devices, including the transfer and qualification of manufacturing processes.
- Prior experience in the design and execution of clinical trials.
- Strategic planning and management of medical device launches.
- Financial planning and budget management.
- Fundraising capabilities.
- Development of organizational structures, including Medical Advisory Boards.
- Understanding of corporate governance.
- History of building and leading dedicated teams to effectively manage the above responsibilities.
- Ability to navigate conflicts towards positive resolutions.
- Willingness to travel internationally as required and conduct meetings during evening hours with manufacturing partners.
- A Master's or Ph.D. in Engineering, Physics, Biology, or a related field is preferred.
- Proficiency in Mandarin or experience collaborating with manufacturers in Taiwan is a plus.