Clinical Affairs Manager (Part-Time)

Aegis Ventures

13h•Remote

About The Position

As the Clinical Affairs Manager (Part-Time), you will lead clinical affairs and drive adoption of our breakthrough fetal monitoring technology. This role will be critical in bridging our innovative technology with clinical practice, supporting regulatory approval, and establishing hospital partnerships. This role will be up to 25 hours a month. This is a part-time position (approximately 25 hours per month) and is remote within the U.S., with periodic travel required to clinical sites. We have a preference for candidates based in major metropolitan areas with access to academic medical centers.

Requirements

Advanced degree (MSN, MD, or PhD) with 5-10 years experience
Direct experience in obstetrics, neonatal care, or women's health preferred
Understanding of fetal monitoring technologies and labor & delivery workflows preferred
Experience with clinical research, preferably medical device studies
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
Medical device or healthcare technology background strongly preferred
Experience working with hospital systems and clinical decision-makers
Understanding of healthcare reimbursement and adoption challenges
Familiarity with quality systems and ISO 13485 requirements

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