Clinical Affairs Manager (MedTech)

TL;DR

Clinical Affairs Manager (MedTech): Leading clinical development and FDA regulatory pathways for a non-invasive fetal EEG monitoring system with an accent on clinical study design and hospital partnerships. Focus on bridging breakthrough EEG technology with clinical practice and overseeing data collection for regulatory submissions.

Location: Remote within the U.S.

Salary: $135–$175 per hour

Company

hirify.global is a venture-backed startup developing the first non-invasive fetal EEG system to eliminate preventable brain injuries at birth and improve neonatal health.

What you will do

• Lead clinical study design and execution across multiple hospital sites.
• Manage relationships with clinical investigators and hospital administrators.
• Support FDA regulatory pathways, including Q-sub preparation and clinical trial protocols.
• Establish partnerships with OB/GYN departments and L&D units to guide workflow integration and user experience.
• Collaborate with engineering and algorithm teams on device usability and EEG analysis validation.
• Oversee clinical data collection and analysis for regulatory submissions.

Requirements

• Advanced degree (MSN, MD, or PhD) with 5-10 years of experience.
• Must be based in the U.S.
• Direct experience in obstetrics, neonatal care, or women's health.
• Knowledge of FDA medical device regulations (510k, PMA pathways) and GCP compliance.
• Experience with clinical trial design and IRB processes.
• Background in medical device or healthcare technology.

Nice to have

• Understanding of fetal monitoring technologies and labor & delivery workflows.
• Familiarity with quality systems and ISO 13485 requirements.
• Understanding of healthcare reimbursement and adoption challenges.

Culture & Benefits

• 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 and USC.