Director, Clinical Research & Regulatory Affairs

Director, Clinical Research & Regulatory Affairs LGTC Group - 3.2 San Jose, CA Job Details Full-time $120,000 - $150,000 a year 1 day ago Benefits Health insurance Dental insurance Vision insurance 401(k) matching Qualifications FDA submissions Statistics Medical writing Clinical research Biostatistics-based research Research Master's degree Statistical analysis ICH guidelines Bachelor's degree Research compliance clinical trial records management Regulatory submissions Research regulatory compliance Full Job Description Company Overview LGTC Group is a leading provider of evidence-based mental health treatment, dedicated to delivering compassionate and innovative care to individuals and families across all age groups. Our multidisciplinary team is committed to advancing mental health through research, clinical excellence, and personalized treatment approaches. About the role LGTC Group is hiring a senior clinical and regulatory lead to run our TMS clinical studies, manage data and statistical analyses, and own FDA communication for our Class II device programs. You will be the person responsible for moving submissions forward — Q-Subs, 510(k) packages, and IDE applications — and for keeping our active studies clean, compliant, and on schedule. What You'll Do Clinical Studies Run our active TMS studies end-to-end: site activation, monitoring, source data review, protocol adherence, and deviation handling. Maintain the Trial Master File per ICH E6(R2) and

ISO 14155

2020. Keep us inspection-ready at all times. Manage patient recruitment and retention for MDD enrollment; track screen-to-enrollment metrics and adjust as needed. Data Management & Statistics Own EDC administration and 21 CFR Part 11-compliant data capture; manage query resolution, database cleaning, and lock procedures. Coordinate with sponsor biostatisticians on SAPs, interim analyses, and primary/secondary endpoint validation (MADRS, PHQ-9, safety outcomes). Translate statistical output into regulatory-ready clinical evidence packages. Maintain ClinicalTrials.gov registrations and results reporting per

FDAAA 801. FDA

Communication & Regulatory Affairs Lead FDA-facing work: pre-submission meetings, Q-Subs, formal responses, and AI/AN resolution. Build 510(k) and IDE packages — predicate device analyses, substantial equivalence arguments, and clinical performance summaries. Maintain accurate records of all FDA correspondence; coordinate sponsor and legal review of draft responses. Align study design, endpoints, and statistical strategy with FDA expectations from protocol inception forward. Safety Reporting Manage AE and UADE identification, causality assessment, and reporting timelines per 21 CFR Parts 803 and 812. Author SAE narratives, MedWatch submissions, and IRB safety reports within required windows. What We're Looking For Required Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field. Master's preferred. 8+ years in clinical research and/or regulatory affairs, with 5+ years in Class II or III medical devices. Direct experience with FDA Class II submissions: 510(k), Q-Sub, and IDE pathways. Working command of 21 CFR Parts 50, 56, 803, 812; ICH E6(R2); and

ISO 14155

2020. Experience overseeing multi-site clinical studies. Hands-on with 21 CFR Part 11-compliant EDC systems; comfortable interpreting biostatistical output. Able to author or critically review CSRs, SAPs, and FDA correspondence independently. Strongly Preferred TMS, rTMS, deep TMS, or related neuromodulation device experience. Prior FDA Q-Sub experience. Experience with accelerated rTMS protocols or MDD endpoints. RAC (RAPS), CCRP, or equivalent credential.

Pay:

$120,000.00 - $150,000.00 per year

Benefits:

401(k) matching Dental insurance Health insurance Vision insurance

Work Location:

Hybrid remote in San Jose, CA 95124