Cer Writer

is a leading Healthcare Artificial Intelligence (AI) company disrupting the 'status quo' by enhancing diagnostic imaging and improving health outcomes with the assistance of machine-supported tools.

taps deep learning technology to provide an automated interpretation of radiology exams like X-rays, and CT scans for time and resource-strapped medical imaging professionals, enabling faster diagnosis and speed to treatment.

aims to democratize healthcare by improving accuracy, accessibility, and affordability to patients worldwide.

Roles and responsibilities:

• Author sections of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical
• Followup (PMCF) reports in compliance with EU MDR 2017/745.Support in PMS activities
• Support in preparing dossier for FDA 510k submissions, including designing clinical validation studies
• Independently monitors activities to compile, update, and maintain regulatory records
• Coordinate with stakeholders from various departments across the company

Requirements:

• Having a keen interest in healthcare
• Able to work independently and as part of a team in getting things done
• Having 25 years of experience in a scientific/medical writing role in the medical device industry
• Able to work in a fast paced environment

Benefits

You will be part of a rapidly growing organization, with an opportunity to work alongside the best minds in the industry.

Competitive compensation and rewards, opportunity to grow with a young company.

Added advantage on:

• Having knowledge of biostatistics
• Current advancements in the field of AI in Healthcare

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