smallTalk, a Northeast Ohio based startup, is seeking a Clinical Product Manager to join our team to participate in and manage projects that apply our technology into the clinical space. This person will be a valuable member of our small team, and will be integral in product development, clinical studies and regulatory submission of a new medical device. They will also participate in product strategy, partnerships and go-to-market strategy, acting as the voice of the customer and consumer for all clinical applications.

smallTalk is focused on brain development in infants and toddlers, with both consumer and clinical applications of our technologies. In 2023, we will be active in new product development, commercialization, and initiation of clinical study for an FDA regulated new medical device. This position will have responsibility for our products with an intended use in the neonatal intensive care unit (NICU).

The Clinical Product Manager will report to the CEO, and will have a broad range of responsibility. These include:

• Product Specifications including hardware, software and firmware
• Maintain current study protocols and optimize communication strategies involved inthese protocols
• Responsible for all aspects of the clinical study, including site training, site visits andcommunication with clinical study sites
• Customer interviews and site visits
• Management and regular communication with regulatory, design and manufacturingvendors
• Adherence to ISO 13485 Quality System
• Project Management
• Team member for industry partnerships and collaboration partners
• Support communication and information sharing with regulatory agencies

Qualifications:

• Bachelor's or advanced degree in a medical subject such as Biomedical Engineering, Nursing, (neonatal) Therapy or Life Sciences.
• 2+ years of relevant experience in a commercial or research environment.
• Proficiency in MS Office [Outlook, Excel, Word] or similar software is required.
• Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required.
• Experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions.
• Flexibility, problem solving capabilities and strategic vision are qualities that will ensure success.
• Detail-oriented, computer proficient and possessing superior interpersonal and organizational skills.

Location:

We currently are virtual, with remote location acceptable. Residency in Northeast Ohio is preferred, with regular travel within the state and to Atlanta, Georgia.

Compensation:

smallTalk offers a competitive pay package including salary, benefits and stock options.