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Regulatory Affairs, Regulatory Compliance , Quality Engineering and Clinical Affairs for active implantable, surgical, combination products and In Vitro Diagnostic (IVD) devices (including Laboratory Developed Tests (LDTs)) from concept through design controls to market and post market.FDA - PMA, HDE, IDE, Traditional, Special, Abbreviated and De Novo 510(k) clearances/approvals.Outside US - CE Marking, Health Canada and TGA approvals.In Vitro Diagnostics (IVD) portfolio with instrument, dry and wet consumables, assays (incl. single site LDTs) and software including Software in & as a Medical Device (SiMD/SaMD) with and without Artificial Intelligence and Machine Learning (AI-ML) and Clinical Decision Support (CDS) Software. Medical devices portfolio with Implantable and non-implantable electronics (hybrid microelectronics including ASICs), fiber optics, firmware/software, capital equipment involving lasers & re-usable surgical instruments.Quality Management Systems creation, deployment and sustenance compliant to FDA, EU, Health Canada, Japan, Brazil ANVISA and other regulations.Substantial executive managerial experience in both start-up and large companies.Specialties: * Medical Device Quality Management System using FDA medical device Regulations (21CFR, QMSR), ISO 13485, European Medical Device Regulations (MDR, IVDR), Canadian Medical Devices Regulations (SOR 98-282), Brazil ANVISA RDCs and Japan PAL (MHLW Ordinance No. 169).* Clinical Lab QMS for LDTs using CLIA (42CFR), CAP and ISO 15189 and bridging to QMSR/ISO 13485.* Design Control including Risk Management using ISO 14971, and Usability and Human Factors using IEC 62366 and AAMI HE 75.* Software Quality Assurance using IEC 62304 and FDA guidances including SaMD and CDS Software.* Manufacturing and Supplier Quality.* Monitoring and Remediation Quality - CAPA, Complaints, MDR, Product Recalls, Field Actions, Corrections and Removals.ASQ Certified : *Manager of Quality/Organizational Excellence (CMQ/OE), *Quality Engineer (CQE), *Reliability Engineer (CRE), *Biomedical Auditor (CBA) & *Quality Auditor (CQA).Regulatory Affairs Professional Society (RAPS) Certified - RAC (US, EU).
Waters Corporation
View- Website:
- waters.com
- Employees:
- 8923
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Senior Director And Head Of Quality Regulatory And Clinical AffairsWaters CorporationBoston, Ma, Us
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Regulatory Affairs ConsultantPictorlabs Inc Nov 2024 - PresentLos Angeles, California, Us -
Senior Advisor Quality Regulatory And Clinical AffairsProclinical Staffing Oct 2024 - PresentCity Of London, London, Gb -
PrincipalYour Raqa Sep 2018 - PresentWith more than 45 years of combined industry experience, Your RAQA provides regulatory compliance services for Medical Device, IVD and LDT to IVD conversion that delivers maximum value to your business with minimal disruption - Multi-site, USA (East & West Coasts) & India (Pune & Chennai).List of services:- US representative for Outside US clients for FDA- Establishment registration and device listing and FDA communication management- Medical device Pre-Submissions- Preparation, advice, review, submission, followup, post market changes and remediation of 510(k), Denovo classification, IDE and PMA applications - Medical device classification- Medical device exempt device identification- Quality Management System Preparation, advice, review, training and remediation- ISO 13485 audits- MDSAP audit support with a current 3rd party MDSAP auditor on staff - Consulting, planning and testing - General Safety IEC 60601-1, EMI/EMC IEC 60601-1-2 and related corollary standards, Biocompatibility/Biological evaluation and toxicology - ISO 10993 series- Clinical evaluation, testing and clinical trials - Consulting, planning and execution of clinical evaluation and trials to meet US FDA requirements- CE marking audits - MDR and IVDR- Technical file preparation, advice, review, submission and followup- Health Canada licensing - IVD and non-IVD/Medical Device classification, preparation, advice, review, submission and followup- Brazil, Japan, Australia licensing, registration and submissionsServices for CLIA labs to meet LDT regulation:- Gap analysis of CLIA lab to LDT regulation- Compliance with Quality Management System requirements of LDT regulation according to timelines- Assay classification- Pre-Submission- 510(k), Denovo classification and PMA submissions- IDE submissions and management of clinical evaluations- Establishment registration and listing- Training of CLIA lab personnel to FDA regulations and LDT regulation and corresponding procedures -
Head Of Ra/Qa And Chief Regulatory OfficerNanomosaic Inc. Jun 2022 - Oct 2024Waltham, Massachusetts, UsChief Regulatory Affairs and Regulatory Compliance Officer for all aspects of regulatory affairs and quality for the company’s products in all geographies. Developed and executed the Company’s regulatory strategy for diagnostic pathway and product development.Developed, implemented and managed a Quality Management System consistent with U.S. FDA and global regulatory requirements, e.g., ISO13485, QSR, IVDR and CMDR and other global regulations, as applicable to IVDs.FDA, ISO, MDSAP and IVD-CE Quality Management Representative. -
Senior Vice President (Svp), Regulatory Affairs & QualityNovasignal Mar 2021 - May 2022Los Angeles, California, UsOversaw all aspects of regulatory affairs and quality for the company’s current and future products in all geographies. Obtained 510(k) clearance for the NovaGuide Trans Cranial Doppler (TCD) system including iOS app NovaGuide View.Obtained Health Canada license for the NovaGuide TCD System.Oversaw the development, implementation and management of a Quality Management System consistent with U.S. FDA and global regulatory requirements, e.g., ISO13485, QSR, MDD/MDR, CMDR (SOR /98-282) and other global regulations, as applicable to medical devices and IVDs.FDA, ISO, MDSAP and MD-CE Quality Management Representative with one successful MDSAP surveillance audit and one successful MDSAP recertification audit. -
Vice President Of Regulatory Affairs & Quality, Health And WellnessAncestry Jan 2019 - Mar 2021Lehi, Ut, UsOversaw the development and implementation of a Quality Management System consistent withU.S. FDA and global regulatory requirements, e.g., ISO13485, QSR, IVDD/IVDR, MDD/MDR and CMDRand other global regulations, as applicable to medical devices and IVDs.Oversaw regulatory affairs pertinent to US, EU and International submissions.• Led the development, implementation and maintenance of a quality management system compliant with applicable global regulations for a complex manufacturing, laboratory and software system• Developed and led a team that meets the QA/QC/Regulatory compliance needs of the business, including hiring, training, planning and execution• Built required regulated systems and processes bridging regulated and non-regulated systems with business efficiencies• Led an existing company into regulatory compliance by engaging stakeholders in developing processes and procedures, communicating requirements to functional areas, training employees.• Led, developed and implemented global quality strategies that ensure operations meet applicable regulations in key markets• Ensured Supplier quality plans, qualifications and approvals• Oversaw the conduct of internal audits in compliance with the US FDA QSR, the European IVDR and MDR, Canadian CMDCAS / MDSAP and ISO13485• Oversaw Quality gap analysis internally and with supplier manufacturers and labs• Ensured accurate documentation is made available for submission to FDA and Notified Body, design dossiers, technical files, post-market submissions and other regulatory documents• Management Representative in formal ISO audits, CE recertification and FDA inspections -
Vice President Of Regulatory Affairs And QualityExosome Diagnostics Dec 2015 - Dec 2018Waltham, Ma, UsResponsible for all aspects of regulatory affairs, compliance and quality for the company’s oncology and non-oncology programs and ensuring FDA-QSR compliance, ISO and other compliance certifications.Additional primary responsibility on product development and engineering.- Implemented and maintained the effectiveness of the Quality Management System.- Responsible for Design Control process to ensure that US FDA-QSR, EU and RoW ISO Quality Management System requirements are met consistently.- Primary contact with regulatory agencies for compliance and global product registrations. Primary interface with the FDA inspectors, ISO, supplier and partner auditors. Lead for internal and external audits and responsible for follow-ups/corrective actions.- Managed FDA submissions, including QSub (Pre-Sub, Pre-IDE) meeting planning, and follow ups.- Worked with R&D (System development and assay development) and Sales & Marketing to develop plans that are in line with regulatory requirements in US, Canada and Europe.- Ensured consistent levels of internal and external compliance throughout development, manufacturing and distribution of products.- Managed the review and final approval process of advertisement and labeling of all products to determine compliance with global labeling requirements.- Hired and worked with external consultants to achieve regulatory aspects of business goals. -
Director Of Regulatory Affairs And Quality AssuranceBio-Rad Laboratories Aug 2014 - Nov 2015Hercules, Ca, Us- Head of Regulatory Affairs and Quality for the Digital Biology Center - Cambridge of Bio-Rad Laboratories.- Led the transition of a Next Generation Sequencing (NGS) IVD product in concept phase through RUO, IUO (IDE) to IVD.- Responsible for all aspects of US, EU and ROW Regulatory Affairs.- FDA, ISO and CE Quality Management Representative.- Developed and maintained ISO 13485:2003 and FDA 21 CFR Part 820 compliance for all areas of the quality management system and entire product lifecycle.- Responsible for developing, submitting and obtaining FDA 510(k) clearance (and/or PMA approval) for DNA sequencing IVD devices.- Responsible for FDA, EU and ROW facility registration, listing, clearances and approvals.- Responsible for supporting product development and implementing documentation required by the In Vitro Diagnostic Directives (IVDD) such as Essential Requirements, IEC 60601/61010 electrical safety, Laser Safety, EMC/EMI and Technical Files.- ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) - Oct. 2014 -
Us Regulatory Affairs And Quality Engineering ManagerBruker Daltonics Dec 2013 - Aug 2014Billerica, Massachusetts, Us- Manager of US Regulatory Affairs- Head of the Quality Engineering department.- Owned Design Control, Risk Management, Supplier Quality, CAPA, Complaints and MDR.- Managed pertinent regulatory files for US, EU and Rest of World (RoW) registration and compliance (510k files and submission, FDA Certificate to Foreign Government - CFG, FDA Certificate of Exportability - CoE, Technical File, etc.)- Developed, implemented, and managed Quality Management System processes and procedures compliant to FDA QSR (21 CFR 820), ISO 13485, and ISO 9001.- Led Design Control initiatives (including Risk Management) from a Quality Engineering perspective for an In Vitro Diagnostic (IVD) device.- Drove CAPA initiatives (including Complaints, MDR and Adverse Event reporting) from concept/creation through verification of effectiveness.- Led the Supplier Quality Program.- Collaborated with engineering, manufacturing, procurement and marketing to perform component qualification, supplier qualification, and other cross functional quality engineering activities.- Led process improvement efforts and quality process lean initiatives.- Regulatory Affairs Certification (RAC - US) - Spring 2014 -
Manager, Qa/RaOmniguide Surgical Sep 2012 - Nov 2013Billerica, Ma, Us- Planned and directed all activities related to development, application, and maintenance of company’s Quality Management System and compliance with relevant regulatory requirements for all processes and products.- Managed Quality System to maintain certification to ISO 13485, CMDR and MDD.- Managed relationship and handle all communications with ISO/CE/CMDCAS registrar.- Managed Technical File for all products.- Managed Sterilization validation and re-validation of ETO and Gamma sterilized products including product bio-burden.- Official Correspondent to FDA and other regulatory agencies (including radiation).- Managed NCMR, CAPA, Suppliers, Internal Audits, and Customer Complaint processes.- Managed Quality Inspection personnel, Document and Records Control personnel.- Oversaw the management of the external environmental monitoring service and compliance with proper operating conditions of Controlled Manufacturing Areas.- Established and managed calibration program.- CAPA - Interacted with external and internal customers and suppliers concerning problems with quality and assure that effective corrective action is implemented.- Led company’s Design Control and Risk Management compliance (including usability and human factors). - Represented Quality and Regulatory Function on new product development projects.- Regulatory Affairs Certification (RAC - EU) - Spring 2013 -
Principal Quality EngineerBd Aug 2011 - Aug 2012Franklin Lakes, New Jersey, Us- Led the quality engineering efforts by guiding new product development (design control) for a micro-electronic and software based medical device.- Led risk management, quality system planning, supplier management including supplier audits, and manufacturing quality planning.- Managed Design History File. - ASQ Certified Reliability Engineer (CRE) - October 2011. -
Principal Quality Systems EngineerSecond Sight Medical Products Dec 2010 - Jul 2011- Created, deployed and managed a ISO 13485 certified, CE compliant and FDA-QSR ready Quality Management System that passed the ISO, CE and FDA audits with no major nonconformances- Served as Subject Matter Expert (SME) during the Notified Body ISO + CE Surveillance Audit.- Successfully obtained CA-FDB clearance for organization
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Senior Quality Engineer & Etq AdministratorSecond Sight Medical Products Aug 2008 - Nov 2010- Served as Subject Matter Expert (SME) during the Notified Body Phase 1 and Phase 2 ISO audits and CE audit to AIMDD - Annex II.- ASQ Certified Quality Auditor - June 2010.- ASQ Certified Biomedical Auditor - March 2010.
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Quality Engineer - IiSecond Sight Medical Products Jul 2007 - Jul 2008- Provided design control, risk management support to product development teams.- Performed electronic QMS software administration, workflow creation, validation and management.- ASQ Certified Quality Engineer - December 2007
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Quality EngineerSecond Sight Medical Products Aug 2005 - Jun 2007- Provided design control support to product development teams.- Performed electronic QMS software administration, and validation.
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Quality Engineering InternSecond Sight Medical Products Jun 2005 - Jul 2005Wrote Quality Management System (QMS) Standard Operating Procedures (SOPs)
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Graduate AssistantUniversity Of Southern California 2000 - 2005Los Angeles, Ca, Us- Administered multimedia courses through online software.- Taught courses in multimedia and desktop publishing
Raajdeep (Raaj) Venkatesan, Ms, Rac, Cmq-Oe, Cba, Cqe Skills
Raajdeep (Raaj) Venkatesan, Ms, Rac, Cmq-Oe, Cba, Cqe Education Details
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University Of Southern CaliforniaMedical Device & Diagnostic Engineering -
University Of Southern CaliforniaElectrical Engineering
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University Of Southern CaliforniaBiomedical Engineering
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Shanmugha Arts, Science, Technology And Research AcademyElectronics & Instrumentation Engineering
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St. Michael'S Academy, Adyar, Chennai, Tamil Nadu, IndiaChemistry & Biology
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What company does Raajdeep (Raaj) Venkatesan, Ms, Rac, Cmq-Oe, Cba, Cqe work for?
Raajdeep (Raaj) Venkatesan, Ms, Rac, Cmq-Oe, Cba, Cqe works for Waters Corporation
What is Raajdeep (Raaj) Venkatesan, Ms, Rac, Cmq-Oe, Cba, Cqe's role at the current company?
Raajdeep (Raaj) Venkatesan, Ms, Rac, Cmq-Oe, Cba, Cqe's current role is Senior Director and Head of Quality Regulatory and Clinical Affairs.
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