Director, Clinical Affairs

Director Of 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

Manage clinical data operations — eCRF design, data review, query resolution, vendor coordination

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

Strong clinical data management knowledge (eCRF, data cleaning, query management, database lock)

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

KOL relationship-building experience