Director Clinical Affairs

We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This is a hands-on, operationally intense role for someone who has taken devices or SaMD from earliest-stage concept all the way through trial completion and into post-market surveillance — not just a single phase of the lifecycle.

• Own the full device/SaMD clinical lifecycle — from early-stage study design through trial execution, final study report, and post-market surveillance
• Develop study design from scratch in close collaboration with internal management, regulatory advisors, reimbursement specialists, and KOL advisory committees
• Lead clinical study execution — feasibility, site selection, activation, enrollment, monitoring, and close-out
• Write and manage IRB/Ethics submissions, informed consent forms, and study essential documents
• Select, qualify, and oversee third-party clinical sites and investigators as primary point of contact
• Develop study timelines, budgets, and risk mitigation plans, reporting clearly to leadership
• Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance
• Manage CRO and clinical vendor relationships, including contract negotiation and performance oversight
• Collaborate cross-functionally with regulatory, product, engineering, and legal teams
• Support RA/QA peers on FDA interactions, pre-subs, and 510(k) submissions
• Build and scale the clinical operations function — SOPs, templates, and tracking systems
• Maintain post-market surveillance activities, including adverse event monitoring and reporting

• Minimum B.S. Degree with 10+ years hands-on clinical operations experience (5+ in leadership) running trials for FDA-regulated medical devices, SaMD/digital health, or combination products
• Demonstrated experience owning a device or SaMD through the complete lifecycle — from initial concept and study design through trial completion and post-market surveillance
• Track record of building study designs from scratch alongside key internal and external stakeholders
• Experience with biosensing devices, consumer health tech, or wellness platforms pursuing clinical validation
• Familiarity with RWE study designs and decentralized/hybrid trial models
• Startup or scale-up experience building processes from scratch
• Experience supporting breakthrough device designations or pre-sub meetings
• Experience launching studies across multiple regions/countries, with direct exposure to varying regulatory bodies and government requirements
• Track record of trials leading to FDA clearances/approvals or labeling expansions
• Experience managing third-party clinical sites end-to-end (selection through close-out)
• Proven ability authoring IRB/Ethics submissions, ICFs, and clinical protocols
• 7+ years cross-functional program management across clinical, engineering, and regulatory
• Fluency in FDA device regulations (IDE, De Novo, 510(k)), ICH-GCP, ISO 14155, and SaMD guidance
• Experience with study budgeting, vendor management, and CRO oversight