Niyati Patel

Dynamic Regulatory Affairs professional with 3.5+ years of experience at Meril Healthcare Pvt. Ltd. Expertise in EU MDR compliance and clinical documentation, coupled with strong analytical and scientific writing skills. Proven ability to prepare high-quality Clinical Evaluation Reports and Technical Files, effectively driving project success and ensuring regulatory adherence and achieve CE certification for various medical devices such as Orthopoedic robotic system and various sutures.

Regulatory Affairs - Scientific Medical Writer at Meril Healthcare Pvt. Ltd. (2023-08 – Present)

• Preparation and Submission of EU-MDR technical files (device description, GSPR, design history file, biocompatibility, risk management, clinical evaluation, IFU, PMS, label) for Sutures, Meshes and other endosurgical and orthopedic products.
• Addressed and documented EU-MDR queries by drafting accurate, compliant responses to support regulatory documentation and audits.
• Preparation and Submission of Clinical documents as per EU MDR i.e. Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), Summary of Safety and Clinical performance report (SSCP) of Endosurgical, Orthopedic and Robotics portfolio.
• Preparation of Clinical Documents as per EU MDD i.e. Clinical Evaluation Report, Literature Search Report (LSR).
• Drafting Post Market Clinical follow-up (PMCF) report and conducting adverse event database research and also post market survilance.
• Preparation of Biological Evaluation Plans and Reports for USFDA submissions (510K).

Medical Writer at Meril Life Sciences Pvt. Ltd. (2022-11 – 2023-06)

• Preparation of outline of manuscript.
• Development of first draft of manuscript.
• Reviewing and Answering author comments.
• Drafting Clinical Study Report (CSR).
• Literature Search.
• Journalistic skills.
• Data analysis.

Doctor of Pharmacy in Pharmacy – Sumandeep Vidyapeeth University, Vadodara (2023)