Clinical Affairs Manager

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.

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 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.

What You'll Do

• Clinical Development & Validation
  • 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
• Hospital Partnerships & Implementation
  • 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
• Cross-Functional Collaboration
  
  • 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

What You'll Need

• Clinical Background
  • 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
• Regulatory & Research 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
• Industry Experience
  • 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

What We Offer

• 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

Salary Range

• $135/hour - $175/hour, depending on experience and alignment with role expectations.