Note: The job is a remote job and is open to candidates in USA. Wavelet Medical aims to revolutionize fetal health monitoring, and they are seeking a Clinical Affairs Manager to lead clinical affairs and drive adoption of their innovative fetal monitoring technology. This role is vital in bridging technology with clinical practice, supporting regulatory approval, and establishing hospital partnerships.
Responsibilities
- Lead clinical study design and execution across multiple hospital sites
- Manage relationships with clinical investigators and hospital administrators
- Support FDA regulatory pathway including Q-sub preparation and clinical trial protocols
- Oversee clinical data collection and analysis for regulatory submissions
- Establish and maintain relationships with OB/GYN departments and L&D units
- Guide clinical workflow integration and user experience optimization
- Support hospital IRB processes and vendor vetting procedures
- Lead clinical training and education programs for adoption
- Work closely with engineering team on device usability and clinical requirements
- Partner with regulatory consultants on FDA strategy and submissions
- Collaborate with algorithm team on clinical validation of EEG analysis
- Interface with business development on hospital partnership negotiations
Skills
- Advanced degree (MSN, MD, or PhD) with 5-10 years experience
- Knowledge of FDA medical device regulations (510k, PMA pathways)
- Experience with clinical trial design, IRB processes, and GCP compliance
- Track record of successful regulatory submissions or clinical study management
- Understanding of biostatistics and clinical data analysis
- Direct experience in obstetrics, neonatal care, or women's health
- Understanding of fetal monitoring technologies and labor & delivery workflows
- Medical device or healthcare technology background
- Experience working with hospital systems and clinical decision-makers
- Understanding of healthcare reimbursement and adoption challenges
- Familiarity with quality systems and ISO 13485 requirements
Benefits
- Remote-first culture with periodic team gatherings
- Healthcare benefits and competitive compensation
- Equity participation in breakthrough medical technology
- Opportunity to directly impact maternal and neonatal outcomes globally
- Collaboration with world-class clinical researchers at Yale, USC, and international partners
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