Digital Therapeutics (DTx) Developer

Job Brief:

About the Role Bacancy Technology is hiring a Digital Therapeutics Developer to build software-based clinical interventions that are regulated as medical devices. Digital therapeutics (DTx) represent a new category of evidence-based treatments delivered through software — from cognitive behavioral therapy apps to substance use disorder interventions. You will develop mobile and web applications that meet FDA Software as a Medical Device (SaMD) requirements, implement clinical trial data collection, and build quality management systems that enable regulatory submissions.About the Role Bacancy Technology is hiring a Digital Therapeutics Developer to build software-based clinical interventions that are regulated as medical devices. Digital therapeutics (DTx) represent a new category of evidence-based treatments delivered through software — from cognitive behavioral therapy apps to substance use disorder interventions. You will develop mobile and web applications that meet FDA Software as a Medical Device (SaMD) requirements, implement clinical trial data collection, and build quality management systems that enable regulatory submissions.

Role: Healthcare Interoperability

Experience: 4+Years

Position Open: 1

Job Location: Iselin Nj

Work from Home Available: Not Available

Salary: Not a constraint for the right candidate

Roles and Responsibility:

Develop mobile and web applications for delivering evidence-based digital therapeutic interventions to patients
Implement quality management systems (QMS) aligned with IEC 62304 software lifecycle and ISO 13485 requirements
Build clinical data collection, patient-reported outcomes (PRO), and electronic data capture (EDC) features for DTx clinical trials
Design and implement software verification and validation (V&V) processes meeting FDA SaMD guidance requirements
Develop patient engagement features including gamification, adherence tracking, clinician dashboards, and outcome measurement
Integrate DTx applications with EHR systems for prescription workflows and clinical data exchange
Implement secure data handling for clinical trial data and patient health information under HIPAA and 21 CFR Part 11
Create comprehensive technical documentation for regulatory submissions including 510(k) and De Novo pathways

Skill Requirement:

Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, or related field
4+ years of software development experience, with at least 2 years in regulated medical software or health tech
Understanding of FDA Software as a Medical Device (SaMD) regulatory framework and classification
Experience with IEC 62304 software lifecycle standard and quality management system requirements
Proficiency in mobile development (React Native, Flutter, or native iOS/Android)
Knowledge of clinical trial design and patient-reported outcome measurement
Experience with secure data handling under HIPAA and 21 CFR Part 11
Strong documentation skills for regulatory submission support

Nice to have

Mobile Development React Native, Flutter, Swift, Kotlin, progressive web apps (PWA)
Regulatory Standards FDA SaMD, IEC 62304, ISO 13485, 21 CFR Part 11, ICH E6 GCP
Clinical Data REDCap, EDC platforms, CDISC/CDASH, patient-reported outcomes (PROs), ePRO
Backend & Cloud Node.js, Python, AWS (HIPAA), Azure, PostgreSQL, encryption, audit trails
Quality & Testing V&V processes, unit testing, integration testing, usability testing, risk analysis (ISO 14971)
Healthcare Integration FHIR R4, ePrescribing, EHR integration, clinical workflow design

Qualification: B.Tech/B.E/MCA

Office Timings: 10.00 AM to 7.00 PM

Perks and Benefits: