Clinical Affairs Lead, Medical Robotics Trials

Regulatory Jobs; Burlingame (CA); On-site; USD 183,000 - 229,000; Full time

Job summary

Neptune Medical in Burlingame, CA is seeking a Senior Manager of Clinical Affairs to lead the end-to-end design, execution, and oversight of clinical studies for a novel robotic platform. You will ensure high-quality, compliant programs that support regulatory submissions and eventual commercialization, working closely with R&D, Regulatory, QA and external partners.

The role demands strategic vision, hands-on leadership in a fast-paced startup, and the ability to manage budgets, CROs, and

Qualifications

• B.S. in Biomedical Engineering, Life Sciences or similar.
• 7–10+ years of clinical research experience in medical devices, including leadership of complex clinical studies.
• Experience developing and executing clinical strategies supporting regulatory submissions.
• Strong working knowledge of GCP, FDA and international regulations, ISO standards.

Responsibilities

• Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives.
• Oversee the design, initiation, execution, monitoring, and closeout of clinical studies with timelines and budgets.
• Provide strategic oversight of CROs, vendors, investigators, and internal teams.
• Develop and review clinical documents for regulatory submissions and audits.

Skills

Clinical strategy

Regulatory submissions

Leadership

Cross-functional teamwork

Regulatory knowledge

Communication

Problem solving

Travel flexibility

Education

B.S. in Biomedical Engineering

Master’s degree in Biomedical Engineering/Life Sciences

Job description

Neptune Medical in Burlingame, CA is seeking a Senior Manager of Clinical Affairs to lead the end-to-end design, execution, and oversight of clinical studies for a novel robotic platform. You will ensure high-quality, compliant programs that support regulatory submissions and eventual commercialization, working closely with R&D, Regulatory, QA and external partners.

The role demands strategic vision, hands-on leadership in a fast-paced startup, and the ability to manage budgets, CROs, and