Wearables Clinical Affairs Lead — FDA & Trials (Remote)

Sempulse; San Diego (CA); Ibrido; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Sempulse is seeking an Opportunistic Clinical Affairs Lead to own FDA regulatory strategy and lead design, planning, and execution of human clinical trials for wearable vital-sign sensors. You will manage FDA/IRB interactions, budgets, and vendor relationships while growing the clinical affairs function for a fast-moving startup.

The ideal candidate combines creativity with rigorous compliance, strong communication, and the ability to work independently or with partners across government and

Competenze

• Bachelors in a related scientific/technical field.
• Expert Clinical Affairs best practices and legal precedent knowledge.
• 3-4+ years of hands-on FDA and/or IRB experience with increasing responsibility, ideally including clinical trials and/or human factors testing.
• Functional knowledge of statistical analyses and reporting.
• Genuine creativity to design compliant, defensible testing scenarios.
• Working knowledge of wearable or sensor technology and clinical affairs best practices.
• Project management experience strongly preferred.
• Exceptional communication and interpersonal skills.
• Strong self-motivation and ability to work from home with little oversight.
• Excellent organization, memory, and attention to detail.
• Time management and juggling multiple workstreams.
• Problem-solving orientation focused on business objectives.
• Office 365 proficiency.
• Claude or another AI-based LLM experience is a plus.

Mansioni

• Own the end-to-end FDA regulatory strategy, from Q-Sub meetings through submissions, for a fast-moving portfolio of non-invasive vital-sign sensors.
• Design, plan, and execute human clinical trials and human factors studies with government and military partners.
• Facilitate FDA and IRB interactions and filings, and keep both moving without bottleneck.
• Translate unconventional testing conditions into protocols that are rigorous, defensible, and fully compliant.
• Manage clinical trial budgets and vendor/CRO relationships, using funding creatively rather than full outsourcing.
• Grow the clinical affairs function as trials scale toward a leadership position in a few years.

Conoscenze

FDA/IRB experience

Wearable tech knowledge

Project management

Office 365 proficiency

Communication & interpersonal skills

Detail-oriented

Self-motivation

Creative problem solving

Formazione

Bachelor’s Degree in a related scientific / technical field

Strumenti

Claude or AI LL M experience

Office 365

Descrizione del lavoro

Sempulse is seeking an Opportunistic Clinical Affairs Lead to own FDA regulatory strategy and lead design, planning, and execution of human clinical trials for wearable vital-sign sensors. You will manage FDA/IRB interactions, budgets, and vendor relationships while growing the clinical affairs function for a fast-moving startup.

The ideal candidate combines creativity with rigorous compliance, strong communication, and the ability to work independently or with partners across government and