Samir B. Email & Phone Number

Florida, United States

Results-driven Manager in Clinical Quality in emerging prominent market. Acts as a seasoned professional with the overall quality assurance and quality management strategy for Biorasi’s clinical projects. Involved in defining and implementing quality assurance processes, procedures, and best practices to ensure compliance with regulatory requirements and industry standards. Conducting audits and inspections to assess compliance with internal quality standards, external regulatory requirements. Develop and maintain a quality management system, including document control, training, and corrective action processes. Collaborate with cross-functional teams to identify and mitigate quality risks and issues throughout the project lifecycle.

India

Lead the process of documentation for import, manufacturing and test license and submissions. Related queries handling and responses to state licensing authority and complianceSuccessfully achieved compliance with CDSCO (SUGAM) requirements for Diasys ProductsEnsured compliance with regulations set by Implementing IVDD (98/79/EC), FDA Part 21 CFR 820QMS compliance to ISO 13485:2016 and ISO 9001:2015Collaborated with research & development team, vendor development team for prototype design and documents for IVD Reagents and IVD Electronic (electrolyte) analyzerConducted vendor assessment, vendor audit, internal audit and process audit for organizationCreated & updated technical files and other regulatory files related to products license, new product registrations or site-specific manufacturing and test registration / re-registration Created calibration plan and third-party calibration process for IVD reagents and InstrumentsSpearheaded complaint activities and tracked all deviation pathways Developed compliance strategies for New Product Development (NPD) division

Mumbai, Maharashtra, India

Ensure compliance with CDSCO (SUGAM), liaising and negotiating with regulatory authorities. Compliance with MDR EU (2017/745).Clinical Investigations and Clinical evaluation reporting(CER).Clinical evaluation plan/reports (CEP/CER), Periodic Safety Update Report(PSUR) and Post Market Clinical Follow-up(PMCF) plan/reports, a summary of safety and clinical performance reports (SSCPs). Compliance with regulations set by MDR EU (2017/745), FDA Part 21 CFR. Clinical Evaluation Report writing according to MEDDEV 2.7/1 revision 4.0, and EU MDR 2017/745. Reviewed technical and trial files related to product licenses, new product registrations, or site-specific registration / re-registration. Spearheaded entire Pharmacovigilance activities globally and tracked all regulatory activities Developed new compliance strategies for New Product Development (NPD)products.

Vapi

Worked in the capacity of Manager Quality Assurance & Regulatory Compliance, involved in employing process mapping and conducting gap analysis, I successfully introduced ABC, TQM, and QBD in SAP QM ECCR/3 (SAP ECC6.0 EHP7.0). This resulted in a significant reduction in product replacement cost by 22% and an improvement in the on-time delivery rate from 45% to 73%. Moreover, I implemented quality initiatives such as ensuring quality system compliance and conducting audits, which led to an average reduction of 13% in company rework cost.

Mumbai

Served as lead quality for Medical IVD devices in compliance with EU MDD regulations. Conducted quality compliance activities for EMC ISO 61326, Safety ISO 61010, Risk Management ISO 14971, Usability Engineering ISO 62366, and Software Lifecycle Development ISO 62304 for Medical Devices. Performing quality control, quality assurance, and quality audit activities for Clinical Chemistry Analyzers. Planning and executing audits, and managing design and development file reviews for new product development (NPD). Conducting software validation for safety and electromechanical testing.

Surat, Gujarat, India

Quality Assurance and Software Validation for Medical Devices