Aegis Ventures
Clinical Affairs Manager (Part-Time)
Remote within the U.S · Mid · Part-time
Sponsorship not specifiedDetected 85 days ago
GCPMachine LearningData AnalysisBusiness DevelopmentSignal ProcessingClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchExperimental DesignCollaborationBiostatistics
About the role
- About the Company Wavelet Medical aims to revolutionize fetal health monitoring to eliminate preventable brain injuries at birth, reduce unnecessary C-sections, and improve outcomes for mothers and their babies.
- While traditional fetal heart rate monitoring is widely used, it has not meaningfully reduced brain injuries and has been linked to increased C-section rates.
- This role will be critical in bridging our innovative 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
- Establish and maintain relationships with OB/GYN departments and L&D units
- Support hospital IRB processes and vendor vetting procedures
- Partner with regulatory consultants on FDA strategy and submissions
- Collaborate with algorithm team on clinical validation of EEG analysis
- Collaboration with world-class clinical researchers at Yale, USC, and international partners
Requirements
- Advanced degree (MSN, MD, or PhD) with 5-10 years experience
- Experience with clinical trial design, IRB processes, and GCP compliance
- Track record of successful regulatory submissions or clinical study management
- Experience working with hospital systems and clinical decision-makers
- Familiarity with quality systems and ISO 13485 requirements
Nice to have
- Understanding of fetal monitoring technologies and labor & delivery workflows preferred
Compensation
- Healthcare benefits and competitive compensation
Benefits
- Healthcare benefits and competitive compensation
- Equity participation in breakthrough medical technology
- Aegis Ventures partners with entrepreneurs and industry leaders to launch and scale transformative companies in digital health and artificial intelligence.
- Wavelet Medical aims to revolutionize fetal health monitoring to eliminate preventable brain injuries at birth, reduce unnecessary C-sections, and improve outcomes for mothers and their babies.
Company info
- Wavelet is building the first non-invasive electroencephalography (EEG) system to measure fetal brain activity during pregnancy and labor.
- Our technology combines novel sensing hardware with advanced signal processing and machine learning to extract clinically meaningful EEG signals from complex biological noise-enabling earlier, more accurate assessment of fetal neurological health without compromising maternal or fetal safety.
- This approach supports better clinical decision-making and healthier outcomes during childbirth.
- We are a venture-backed, early-stage medtech company advancing toward FDA clearance of a Class II medical device.
- About the Job
- 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 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.
Equal opportunity
- Aegis Ventures is a proud Equal Opportunity Employer - we recruit, train, compensate and promote our team members based on qualifications.
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