Clinical Evaluation Specialist — EU MDR CEP/CER

Socket.dev; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA, seeks a Regulatory Medical Writer to lead CEP and CER development for CE Mark submissions, ensuring compliance with EU MDR and US regulations. This role requires strong literature review, data interpretation, and ability to draft clear clinical sections.

You will work with cross-functional teams across regulatory, engineering, and post-market surveillance to plan strategy, produce accurate documentation, and manage timelines for multiple projects while

Qualifications

• Experience in CEP and CER development for regulatory submissions.
• Minimum of 2 years of medical writing experience.
• Ability to identify critical information needs and involve stakeholders in decision-making for clinical evaluation.
• Strong experience in literature search, review, and data appraisal.
• Demonstrated ability to communicate clearly in technical writing; strong scientific writing skills.
• Excellent critical thinking and analytical skills.
• Detail-oriented with strong organizational abilities.
• Ability to work effectively with cross-functional teams.
• Experience with protocol development and clinical sections for regulatory submissions.

Responsibilities

• Define strategy for CEPs and CERs for new products requiring CE Mark.
• Develop and author clinical documentation for regulatory submissions, mainly CEP sections and the CER.
• Develop and respond to regulatory authority questions on clinical documentation.
• Review literature and summarize data on risks, therapies, and device benefits.
• Critically appraise literature and write clinical summaries for products and procedures.
• Manage CEP/CER timelines with product development teams and regulatory bodies.
• Support broader Clinical/Medical Affairs activities for regulatory submissions and communications.
• Ensure compliance with SOPs and regulatory requirements (GCP, US/OUS).

Skills

CEP development

CER writing

Literature review

Scientific writing

Regulatory submissions

Project management

Cross-functional teamwork

Attention to detail

Communication skills

Education

MD/PhD/MS in scientific field

Job description

Intuitive Surgical in Sunnyvale, CA, seeks a Regulatory Medical Writer to lead CEP and CER development for CE Mark submissions, ensuring compliance with EU MDR and US regulations. This role requires strong literature review, data interpretation, and ability to draft clear clinical sections.

You will work with cross-functional teams across regulatory, engineering, and post-market surveillance to plan strategy, produce accurate documentation, and manage timelines for multiple projects while