Scientist Medical Writing

📋 Description

• Write Clinical Evaluation Plans.
• Write CERs compliant with local procedures and regulations.
• Create SSR reports in compliance with local procedures and regulations.
• Link CER/SSR files to Quality Systems and regulatory docs.
• Develop schedules to meet CER/SSR timelines.
• Participate in workshops to define CER processes and industry practices.
• Support audits; act as SME for CER/SSR audits.

🎯 Requirements

• Graduate or post-graduate in Life Sciences with 3+ years in medical writing.
• Experience in medical device industry and CER regulatory requirements.
• Knowledge of quality regulatory compliance, adverse event reporting, risk management.
• Regulatory/audits or Notified Body audit experience preferred.
• Collaborates with Medical Directors, PMS, Design Quality Engineers, R&D, Regulatory.