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Ashish Yadav
RA/QA Manager
Sinclair Pharma PLC
Medical Devices/ Pharmaceuticals
470 White Cap Ln
Newport Beach
Devices, Pharmaceuticals, Biologics, IVD, Biotechnology
Detailed, accomplished professional with 7+ years of comprehensive experience in regulatory affairs and quality. Thorough knowledge of Good Manufacturing Practices (GMP), Quality System Requirements (QSR), ISO-13485 and 14971, and Medical Device Directive (MDD). Skilled at writing and editing materials for regulatory submissions, risk analysis, regulatory compliance audits, supplier qualification audits, QA and QC data analysis, design history file and device master record maintenance. A successful record of interpreting and implementing standards, regulatory filings, vendor management, FDA inspections, complaint management, and regulatory agency interaction.
 Compiled regulatory dossier for registering class I, II & III medical devices in US, EU, APAC, & Middle Eastern countries.
 Maintained document change control, NCMRs, CAPA, and complaint handling.
 Managed teams to perform validation, risk analysis and continuous improvement using six sigma methodologies.
 Worked extensively with Engineering and Operations on new product development, and design control changes.
 Chaired Material Review Board meetings with R&D, Production, and Sales & Marketing.
 Developed and executed software (Part 11 compliant) and equipment validation protocols (IQ, OQ, PQ).
 Ensured successful outcomes to three FDA inspections by implementing a quality system that meets all aspects of regulatory compliance.
SINCLAIR PHARMACEUTICALS LTD., Chester, UK (09/2014- Present)
Regulatory Affairs and Quality Assurance Manager/Management Representative
 Representing a US company with FDA, Notified Body & international regulatory agencies regarding company’s regulatory strategies & submissions. Leading 510k, & IDE projects for a Class II medical device.
 Managing relationship with our contract manufacturer for all the quality and regulatory aspects.
 Liaising with US laboratory service providers for conducting different studies required for submissions.
 Reviewing all product complaints & ensuring timely reporting of those events to regulatory agencies as necessary.
 Making decisions regarding all Quality System related activities, and Facilitating Quality Improvement Programs and work toward 100% "Right the First Time".
 Ensuring training of employees on Quality Systems Regulation & key international regulations & standards including US FDA laws, regulations & guidelines;
 Leading the product development teams on behalf of regulatory, quality & Research and Development.
SILHOUETTE LIFT, INC., Irvine, CA (09/2013 – 09/2014)
Regulatory Affairs & Quality Assurance Manager/Management Representative
 Worked on successful submission of a Class II 510k submission to US FDA.
 Compilation of regulatory dossier for registering Class II medical device in foreign countries.
 Responsible to assure compliance with domestic & international quality and regulatory requirements.
 Responsible to make all the decisions related to Regulatory/Quality System activities along with assignments like NCRs, CAPA, and Supplier/Customer Complaints.
 Interfacing with suppliers, engineers, and/or contractors effectively resolving conflicts and achieving objectives related to the product or the raw material along with hosting external audits such as customer and third party audits.
 Preparing & submitting technical dossier for CE Marking to obtain approval to commercialize new & existing devices in European Union.
 Writing, reviewing and approving validation plans, protocols and reports.
 Identifying & evaluating opportunities for improvement and making specific recommendations for adoption.
CONSULTANT, Los Angeles, CA (01/2012 – 08/2013)
RA/QA Engineer II, Specialty Silicone Fabricators
 Gained compliance with FDA QSR and ISO-13485 regulations by evaluating and modifying Standard Operating Procedures (SOP).
 Handling customer complaint (CC), Non-Conforming (NC), and CAPA system per procedures.
 Hosting external audits such as FDA inspections, customer and third party audits along with creating Audit plans.
 Quality System Management
 Regulatory Submissions
 Compliance Audits
 EU, ISO, FDA, ICH Regulations
 Batch Record Review
 Lot Release
 Inspection Preparation
 Method/Equipment Validation
 Six Sigma methodologies
 New Product Development
Quality Engineer/Validation Engineer Consultant, Medtronic
 Supported new product development and generated required documentation in support of manufacturing processes.
 Participated in continuous improvement, and coordinated with the suppliers, engineers, and contractors to prepare, write and execute validation protocols & reports.
Regulatory Affairs/Quality Assurance Consultant, Posey Company
 Led Quality system, vendor programs, complaint handling, quality engineering, new product design reviews, process validations, document control, and incoming and in-process inspection.
 Acted as a chairperson for MRB meetings to discuss the discrepancies and the status of the product, processes, and their related CAPA investigations, SCAR and NCRs.
 Responded and investigated customer complaints, non-conformances and creating reports.
Regulatory Affairs/Quality Assurance Consultant, PSC Biotech
 Responsible for validation activities, complaint management including risk analysis, continuous improvement and maintenance of quality management system throughout the company.
 Developed procedures for quality system implementation.
Regulatory Affairs Consultant, Neutrogena
 Responsible for developing, and maintaining change control database, document routes.
 Supported production validation activities including IQ/OQ/PQ, equipment calibration and internal audits.
 Reviewed manufacturing batch records along with maintenance of records, protocols and reports for quality & regulatory submissions.
Quality Assurance Supervisor
 Supervised 20 employees for the implementation of risk management program, complaint handling, document control & tracking.
 Handled batch record review and quality control data analysis regarding lot release devices.
PRIOR EXPERIENCE (2006 to 2009)
GARLE IMPEX, India (Biomedical Engineer, RA/QA) ~ P.G.I Medical Sciences (Intern) ~ Mohan Meakins Pvt. Ltd. (Intern) ~ Indraprashtha Apollo Hospitals (Intern)
Six Sigma Green Belt Certification
ISO 13485:2003 Internal Auditor Certification
Total Quality Management Certification
Certificate for Understanding Patent and Patent Application Process
Corrective and Preventive Action(s) Workshop (University of Southern California, Los Angeles, CA)
Company Audit Workshop (University of Southern California, Los Angeles, CA)
Risk Management Workshop (University of Southern California, Los Angeles, CA)
UNIVERSITY OF SOUTHERN CALIFORNIA, Los Angeles, CA Master of Science, Biomedical Engineering
I.E.T. BUNDELKHAND UNIVERSITY, India Bachelor of Technology, Biotechnology Engineering
Regulatory Affairs Professional Society (RAPS), American Society for Quality (ASQ), Orange County Regulatory Affairs Network (OCRA)
Minitab, Visio, MS Excel, Word, Project, Access, Matlab, Simulink, Mathematica and Document Control Databases such as UniPoint, Documentum, FDA ComplianceWire, Agile, ETQ, Trackwise and CONNECT.