Clinical Affairs Manager – Part-Time

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the design and implementation of clinical studies across various hospital locations.

• Cultivate and manage relationships with clinical investigators and hospital management.

• Assist in navigating the FDA regulatory process, including the preparation of Q-submissions and clinical trial protocols.

• Supervise the collection and analysis of clinical data for regulatory submissions.

• Build and maintain partnerships with OB/GYN departments and labor & delivery units.

• Facilitate the integration of clinical workflows and enhance user experience.

• Aid in the hospital IRB processes and the evaluation of vendors.

• Lead clinical training and educational initiatives to promote adoption.

• Collaborate closely with the engineering team to address device usability and clinical needs.

• Work in partnership with regulatory consultants on FDA strategies and submissions.

• Collaborate with the algorithm team to validate clinical EEG analysis.

• Coordinate with business development on negotiations for hospital partnerships.

⛳️ Requirements

• An advanced degree (MSN, MD, or PhD) with 5-10 years of relevant experience.

• Preferred direct experience in obstetrics, neonatal care, or women's health.

• Familiarity with fetal monitoring technologies and labor & delivery processes is preferred.

• Experience in clinical research, particularly with medical device studies.

• Knowledge of FDA medical device regulations, including 510k and PMA pathways.

• Proficient in clinical trial design, IRB processes, and GCP compliance.

• Proven history of successful regulatory submissions or management of clinical studies.

• Understanding of biostatistics and clinical data analysis.

• A strong background in medical devices or healthcare technology is preferred.

• Experience working with hospital systems and clinical decision-makers.

• Familiarity with healthcare reimbursement and adoption issues.

• Knowledge of quality systems and ISO 13485 standards.

🏝️ Benefits

• Emphasis on a remote-first culture with occasional team meetups.

• Comprehensive healthcare benefits and competitive salary.

• Equity participation in innovative medical technologies.

• Chance to make a significant impact on maternal and neonatal health outcomes worldwide.

• Opportunities to collaborate with leading clinical researchers at Yale, USC, and international partners.