Director, Clinical Trials for Medical Devices & SaMD

BioTalent; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

BioTalent is seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company.

The role is hands-on and operationally intensive, requiring leadership across design, execution, and post-market surveillance for devices and SaMD. You will drive study design, timelines, budgets, and compliance, collaborating with regulatory, product, and legal teams to enable FDA clearances and market success.

Qualifications

• Minimum B.S. Degree with 10+ years hands-on clinical operations experience in FDA-regulated medical devices or SaMD.
• Experience owning device/SaMD lifecycle from concept through post-market surveillance.
• Familiarity with biosensing devices, consumer health tech, or wellness platforms.

Responsibilities

• Own the full device/SaMD clinical lifecycle from design to trial execution and post-market surveillance.
• Lead study design in collaboration with regulatory advisors, reimbursement specialists, and KOLs.
• Oversee site activation, enrollment, monitoring, and close-out of clinical studies.
• Manage IRB/Ethics submissions and essential documents (ICFs, protocols).
• Select and oversee third-party clinical sites and investigators as primary contacts.
• Develop timelines, budgets, and risk mitigation plans; report to leadership.
• Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820) and ICH-GCP/ISO 14155.
• Manage CRO/vendor relationships and contract negotiation.
• Collaborate cross-functionally with regulatory, product, engineering, and legal teams.
• Support FDA interactions, pre-submissions, and 510(k) submissions.
• Build and scale the clinical operations function with SOPs and tracking systems.
• Maintain post-market surveillance including adverse event monitoring.

Skills

Clinical operations

FDA regulations

IRB/Ethics submissions

CRO management

cross-functional PM

Study design

Budget planning

Post-market surveillance

Regulatory filings

Education

Bachelor's degree

Job description

BioTalent is seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company.

The role is hands-on and operationally intensive, requiring leadership across design, execution, and post-market surveillance for devices and SaMD. You will drive study design, timelines, budgets, and compliance, collaborating with regulatory, product, and legal teams to enable FDA clearances and market success.