Pooja Solanki Email & Phone Number

Surat, Gj, In

Bengaluru, Karnataka, India

• To develop literature search and review protocols.• Author end to end CSRs, SSCPs, IBs, CEPs, CERs, PMCFER, and various other clinical regulatory documents with specific focus on sections that require critical analysis and summarization of device safety and performance data.• Perform gap analysis for medical device technical documents and prepare a list of pending assets.• Perform peer review for various regulatory documents and technical review of CEPs, CERs, CSRs, and other… Show more • To develop literature search and review protocols.• Author end to end CSRs, SSCPs, IBs, CEPs, CERs, PMCFER, and various other clinical regulatory documents with specific focus on sections that require critical analysis and summarization of device safety and performance data.• Perform gap analysis for medical device technical documents and prepare a list of pending assets.• Perform peer review for various regulatory documents and technical review of CEPs, CERs, CSRs, and other regulatory documents.• Evaluate client review comments, if necessary, and communicate reviewer feedback to the project manager to ensure consistency in the data presented. Show less

Vapi

• Experienced in drafting literature search protocols, screening of scientific literature, and summarizing clinical data.• Responsible for drafting Protocols, ISRs, CSRs, CEPs, CERs, literature search protocols and reports, SSCPs, PMCF protocol, and PMCF report for various range of medical devices.• Supported clinical operation & medical writing teams for design, development and documentation of clinical study data.• Participated in external audits: CE, ISO, CMDCAS audit for… Show more • Experienced in drafting literature search protocols, screening of scientific literature, and summarizing clinical data.• Responsible for drafting Protocols, ISRs, CSRs, CEPs, CERs, literature search protocols and reports, SSCPs, PMCF protocol, and PMCF report for various range of medical devices.• Supported clinical operation & medical writing teams for design, development and documentation of clinical study data.• Participated in external audits: CE, ISO, CMDCAS audit for cardiovascular devices registration and surveillance.• Combined understanding of scientific and research methodology, medical device regulations and guidelines and product knowledge to support regulatory affairs submissions for CE marking of new devices and renewal of CE mark for existing devices in accordance with MEDDEV 2.7.1 rev4 and EU MDR 2017/745. Show less

Surat, Gujarat, India

• Responsible for coordination & preparation of regulatory submissions, renewal submission, variation preparation submission for cardiovascular devices.• Prepare, submit & manage final product files submissions (Design Dossier) and communicate effectively with regulatory authorities to obtain timely product approvals• Possess good knowledge of Medical Device regulations in European Union Countries (MEDDEV & MDR 745/2017)• Coordinated with European Representatives for regulatory… Show more • Responsible for coordination & preparation of regulatory submissions, renewal submission, variation preparation submission for cardiovascular devices.• Prepare, submit & manage final product files submissions (Design Dossier) and communicate effectively with regulatory authorities to obtain timely product approvals• Possess good knowledge of Medical Device regulations in European Union Countries (MEDDEV & MDR 745/2017)• Coordinated with European Representatives for regulatory requirements specific to the medical devices• Responsible for preparation and submission of Technical File for CE Certification Application• Responsible for preparation/update of Quality Management System Documents per the Quality Management System Standards (ISO 9001, ISO 14971 & ISO 13485)• Responsible for documentation of regulatory and statutory guidelines and applicable standards Show less

M.S. Pharm, Medical Devices, Gold Medalist In Masters Program.

Activities and Societies: Development of Bone regenerative Devices, Polymer Analysis, Biocompatibility Study I was working as a research.

Bachelor Of Pharmacy (Bpharm), Pharmaceutical Sciences, 7.93 Cgpa