Joe S. Email & Phone Number

Experienced Regulatory affairs associate with hands-on experience in cardiovascular devices and IVD.

• Regulatory Affairs Associate

  Qaaf Healthcare International

  Jan 2021 - Dec 2022 - Delhi, India

  Prepared clinical trial protocol, including design, methodology, and reviewedPrepared documentation in support of regulatory filings and submission in the US, EU etc.Regulatory impact assessment for changes to design, labelling, process, and engineering specifics for medical devices and assist in the development of 510(k) submissionExpertise in Literature search: Experienced in conducting focused literature searches on PubMed, ScienceDirect, or other similar medical literature databases and clinical evidence mapping, managing the literature database, and preparing literature reviewsNarrative Writing of Adverse events reported for various drugs and devicesPre-Screening document review: Scrutinizing Pre-screening documentsCreating and editing device-related technical PowerPoint presentations for international clients.Worked on interdisciplinary teams during new device development, design and label/IFU changes, providing feedback on the regulatory status.