[Remote] Clinical Affairs Manager (Part-Time)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company aims to revolutionize fetal health monitoring, and they are seeking a Clinical Affairs Manager to reputed company clinical affairs and drive adoption of their innovative fetal monitoring technology. This role is vital in reputed company technology with clinical reputed company, supporting regulatory approval, and establishing hospital partnerships.
Responsibilities
- reputed company clinical study design and execution across multiple hospital sites
- Manage relationships with clinical investigators and hospital administrators
- Support FDA regulatory reputed company including Q-sub preparation and clinical trial protocols
- reputed company clinical data collection and analysis for regulatory submissions
- Establish and maintain relationships with OB/GYN departments and L&D reputed company
- Guide clinical workflow integration and user experience optimization
- Support hospital IRB processes and vendor vetting procedures
- reputed company clinical training and education programs for adoption
- Work closely with engineering team on device usability and clinical requirements
- Partner with regulatory consultants on FDA reputed company and submissions
- Collaborate with algorithm team on clinical validation of EEG analysis
- reputed company 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 reputed company)
- Experience with clinical trial design, IRB processes, and GCP compliance
- reputed company record of successful regulatory submissions or clinical study management
- Understanding of biostatistics and clinical data analysis
- reputed company experience in obstetrics, neonatal care, or women's health
- Understanding of fetal monitoring technologies and labor & delivery workflows
- Medical device or reputed company technology background
- Experience working with hospital systems and clinical decision-makers
- Understanding of reputed company reimbursement and adoption challenges
- Familiarity with reputed company systems and ISO 13485 requirements
Benefits
- Remote-first culture with periodic team gatherings
- reputed company benefits and competitive compensation
- Equity participation in reputed company medical technology
- Opportunity to directly reputed company maternal and neonatal reputed company globally
- Collaboration with world-class clinical researchers at reputed company, USC, and international partners
reputed company