Medical Writer

About the Role

The Medical Writer develops, writes, and edits high-quality clinical and regulatory documentation required to support the development, registration, and post-market surveillance of medical devices. This role works closely with Clinical Affairs, Regulatory Affairs, R&D, and Quality Engineering to interpret clinical data and ensure compliance with global standards.

To Make an Impact, You Will:

• Audit, edit, and maintain clinical and regulatory documents, including Clinical Evaluation Reports (CERs), Clinical Study Protocols and Reports (CSPs/CSRs), Investigator's Brochures (IBs), IFUs, Post-Market Clinical Follow-up (PMCF) plans and reports, and risk management documentation. Ensures compliance to applicable regulations and guidance's (ISO13485, ISO14155, ISO14791, MDR, and EU and FDA guidance documents) and applicable Pulse Biosciences SOPs.
• Collaborate with Clinical, Regulatory, Quality, Biostatistics and R&D Engineering to ensure aligned messaging and data interpretation across submissions.