Clinical Evaluation Scientist (Remote)

Intuitive; Sunnyvale (CA); On-site; USD 106,000 - 179,000; Full time

Job summary

Intuitive Surgical seeks a qualified medical writer to develop CEPs and CERs for CE Mark regulatory submissions, drawing on expertise in clinical literature, trials data, and regulatory standards. The role collaborates with engineering, regulatory, and clinical teams to craft CEPs and CERs, respond to regulatory requests, and maintain EU product conformance through ongoing updates.

Strong communication and scientific writing skills are essential, along with knowledge of GMP/GCP guidelines and

Qualifications

• Minimum of 2 years of medical writing experience.
• Experience developing CEPs and CERs for regulatory submissions.
• Strong ability to review and summarize scientific literature.

Responsibilities

• Develop CEPs and CERs for CE Mark submissions.
• Draft responses to regulatory requests and questions.
• Collaborate with engineering, regulatory, and clinical teams to maintain EU product conformance.
• Perform literature searches and summarize data for risk assessment.
• Ensure compliance with GCP and regulatory guidelines.

Skills

Medical writing

Literature reviews

Regulatory submissions

Regulatory knowledge

Communication

Education

MD, PhD or MS in a scientific field

Job description

Intuitive Surgical seeks a qualified medical writer to develop CEPs and CERs for CE Mark regulatory submissions, drawing on expertise in clinical literature, trials data, and regulatory standards. The role collaborates with engineering, regulatory, and clinical teams to craft CEPs and CERs, respond to regulatory requests, and maintain EU product conformance through ongoing updates.

Strong communication and scientific writing skills are essential, along with knowledge of GMP/GCP guidelines and