Director Clinical Affairs

BioTalent; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

BioTalent seeks a Director of Clinical Affairs to own end-to-end regulatory-driven clinical studies for a growing medical device company. This hands-on role covers design, execution, reporting, and post-market surveillance across device and SaMD programs.

Ten-plus years in clinical operations for FDA-regulated devices, with leadership experience and proven ability to build processes from the ground up are required. Expect interaction with regulatory, product, engineering and legal teams.

Qualifications

• Minimum B.S. degree with 10+ years in clinical operations for FDA-regulated medical devices or SaMD.
• Experience owning device or SaMD trials from concept to post-market surveillance.
• Ability to design studies with internal and external stakeholders.
• Familiarity with biosensing/health tech a plus.

Responsibilities

• Own full device/SaMD clinical lifecycle from design to post-market surveillance.
• Develop study designs with management, regulatory advisors, and KOLs.
• Lead study execution: feasibility, site activation, enrollment, monitoring, close-out.
• Manage IRB submissions, informed consent forms, and essential documents.
• Oversee third-party sites and investigators as primary contact.
• Develop timelines, budgets, and risk mitigation reports for leadership.
• Ensure compliance with FDA regs, ICH‑GCP, ISO 14155, and SaMD guidance.
• Manage CRO/vendor relationships and contracts.
• Collaborate cross-functionally with regulatory, product, engineering, and legal teams.
• Support FDA interactions and 510(k) submissions; scale clinical ops function.
• Maintain post-market surveillance, including AE monitoring and reporting.

Skills

Regulatory affairs

Clinical operations leadership

FDA regulations (IDE/De Novo/510(k))

IRB/Ethics submissions

Study design & lifecycle ownership

Vendor/CRO management

Cross-functional collaboration

Budgeting & timelines

Education

Bachelor's degree in a relevant field

Job description

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.

What You'll Do

• 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

What You Bring

• 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