Remote Regulatory Medical Writer (CEP/CER)

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

Job summary

Intuitive Surgical, Inc. is seeking a Clinical Scientist (Finance) to develop CEPs and CERs and support EU MDR and CE mark submissions. You will review literature, draft regulatory documentation, and coordinate cross-functional teams to ensure timely updates and conformance.

This remote role demands strong scientific writing and regulatory know-how across global programs. The position emphasizes rigorous documentation, project management, and collaboration with Medical Sciences and Regulatory

Qualifications

• In-depth therapeutic and device knowledge applied to CEP/CER development.
• 2+ years medical writing experience.
• Strong scientific writing and literature review capabilities.

Responsibilities

• Develop CEPs and CERs for new products requiring CE Mark.
• Author clinical documentation for regulatory submissions.
• Respond to regulatory queries on clinical documentation.
• Stay informed on literature and clinical landscape trends.
• Ensure compliance with GCP and regulatory requirements.

Skills

Literature review

Scientific writing

Regulatory submissions

Project management

Cross-functional teamwork

Attention to detail

Education

MD/PhD/MS

Job description

Intuitive Surgical, Inc. is seeking a Clinical Scientist (Finance) to develop CEPs and CERs and support EU MDR and CE mark submissions. You will review literature, draft regulatory documentation, and coordinate cross-functional teams to ensure timely updates and conformance.

This remote role demands strong scientific writing and regulatory know-how across global programs. The position emphasizes rigorous documentation, project management, and collaboration with Medical Sciences and Regulatory