Ranjani S

About Ranjani S

Medical Writer with 3+ years of experience in the medical device industry, Helps to communicate complex scientific information with clarity and precision. My expertise spans regulatory compliance, clinical research, and technical writing, ensuring high-quality documentation that meets global regulatory standards- Class I, II, and medical devices- EU MDR, FDA regulations (21 CFR 820, 801, and 807), and ISO 13485- Clinical Evaluation Reports (CERs)- Technical Files and Design Dossiers- Developing high-quality, regulatory-compliant documentation- Conducting literature reviews, literature screening, summarization and analyzing clinical data- Collaborating with cross-functional teams to ensure timely delivery- Implementing document control processes to ensure quality and compliance- Creating user manuals, instructions for use (IFU), and labelling Authored clinical evaluation & PMS technical files, and design dossiers- Improved documentation quality and reduced review cycles- Developed and maintained documentation templates and style guide- Participating in industry conferences and workshopMedical Writer, Medical Devices, Regulatory Compliance, Clinical Research, Technical Writing, EU MDR, FDA, ISO 13485.

Experience

1. Medical Writer

   HCLTech

   Aug 2022 — Present · Chennai, IN

Education

• SMK FOMRA INSTITUTE OF TECHNOLOGY

  B.E, Biomedical/Medical Engineering